FDA event 76201 · Recall Observatory

device · product 1 of 12

ETEST Ceftazidime TZ256 Foam packaging, Product Name: ETEST Ceftazidime TZ 0.016-256. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions

Z-1521-2017

Recall number: Z-1521-2017
Initiated: December 15, 2016
Classification: Class II
Status: Terminated
Recalling firm: BioMerieux SA
Quantity: unknown

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

Code information

Reference no. 506758, Lot #1003693010, 003922720, 003945330, 004193850, 004325620, 004427220, 004510540, 1004720640 & 1004830190 and Reference no. 506718, Lot #1003788640, 1003823960, 1003945320, 1004427210, 1004510360, 1004719300 &1004830170.

Distribution pattern

Worldwide Distribution - U.S.( Nationwide); Foreign: Utd.Arab Emir., Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Russian, Fed. Sweden, Singapore, Thailand, Turkey, South Africa, Indonesia, Peru, Saudi Arabia, Gabon, Kazakhstan, Philippines, Ivory Coast, Venezuela, Kenya, Serbia, Tunisia, Macedonia, Lebanon, Romania, Benin, Bosnia-Herz., Oman, Uruguay, Lithuania, Burkina Faso, Slovenia, Qatar, Kuwait, Costa Rica, Paraguay, Dominican Republic, Croatia, Panama, Congo, Dem. Rep. Congo, Honduras, Estonia, Latvia, Cambodia, Bulgaria, Vietnam, Dutch Antilles, Nicaragua, Israel, Georgia, Palestine, Egypt, Pakistan (includ.Afghanistan), Malta, Jordan Bahrain, El Salvador, Nigeria, Dutch Antilles, Iran, Belarus, Zimbabwe, Morocco, Mauretania, Anguilla, Philippines, Malaysia, Turkmenistan, Guam, Brunei, Bolivia, Guatemala, Ecuador, Belarus, Mongolia

device · product 2 of 12

ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 0.016-256. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions

Z-1522-2017

Recall number: Z-1522-2017
Initiated: December 15, 2016
Classification: Class II
Status: Terminated
Recalling firm: BioMerieux SA
Quantity: unknown

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

Code information

Reference no. 503558, Lot #1003158260 and Reference no. 503518, Lot #1003161140.

Distribution pattern

Worldwide Distribution - U.S.( Nationwide); Foreign: Utd.Arab Emir., Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Russian, Fed. Sweden, Singapore, Thailand, Turkey, South Africa, Indonesia, Peru, Saudi Arabia, Gabon, Kazakhstan, Philippines, Ivory Coast, Venezuela, Kenya, Serbia, Tunisia, Macedonia, Lebanon, Romania, Benin, Bosnia-Herz., Oman, Uruguay, Lithuania, Burkina Faso, Slovenia, Qatar, Kuwait, Costa Rica, Paraguay, Dominican Republic, Croatia, Panama, Congo, Dem. Rep. Congo, Honduras, Estonia, Latvia, Cambodia, Bulgaria, Vietnam, Dutch Antilles, Nicaragua, Israel, Georgia, Palestine, Egypt, Pakistan (includ.Afghanistan), Malta, Jordan Bahrain, El Salvador, Nigeria, Dutch Antilles, Iran, Belarus, Zimbabwe, Morocco, Mauretania, Anguilla, Philippines, Malaysia, Turkmenistan, Guam, Brunei, Bolivia, Guatemala, Ecuador, Belarus, Mongolia

device · product 3 of 12

ETEST¿ Ceftriaxone TXL32 SPB, Product Name: ETEST¿ Ceftriaxone TX 0.002-32(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions

Z-1523-2017

Recall number: Z-1523-2017
Initiated: December 15, 2016
Classification: Class II
Status: Terminated
Recalling firm: BioMerieux SA
Quantity: unknown

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

Code information

Reference no. 412302, Lot #1002939460, 1003361690, 1003848910, 1004041770, 1004394530, 1004731200 & 1004876830 and Reference no. 412303, Lot # 1002939450, 1003089900, 1003813690, 1003851120, 1003953500, 1004152070, 1004315690, 1004394520, 1004525320, 1002939450, 1003089900, 1004755940, 1004828440, 1004876840 & 1005118100.

Distribution pattern

Worldwide Distribution - U.S.( Nationwide); Foreign: Utd.Arab Emir., Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Russian, Fed. Sweden, Singapore, Thailand, Turkey, South Africa, Indonesia, Peru, Saudi Arabia, Gabon, Kazakhstan, Philippines, Ivory Coast, Venezuela, Kenya, Serbia, Tunisia, Macedonia, Lebanon, Romania, Benin, Bosnia-Herz., Oman, Uruguay, Lithuania, Burkina Faso, Slovenia, Qatar, Kuwait, Costa Rica, Paraguay, Dominican Republic, Croatia, Panama, Congo, Dem. Rep. Congo, Honduras, Estonia, Latvia, Cambodia, Bulgaria, Vietnam, Dutch Antilles, Nicaragua, Israel, Georgia, Palestine, Egypt, Pakistan (includ.Afghanistan), Malta, Jordan Bahrain, El Salvador, Nigeria, Dutch Antilles, Iran, Belarus, Zimbabwe, Morocco, Mauretania, Anguilla, Philippines, Malaysia, Turkmenistan, Guam, Brunei, Bolivia, Guatemala, Ecuador, Belarus, Mongolia

device · product 4 of 12

Ciprofloxacin CI 32 Foam packaging, Product Name: ETEST Ciprofloxacin CI 0.002-32. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions

Z-1524-2017

Recall number: Z-1524-2017
Initiated: December 15, 2016
Classification: Class II
Status: Terminated
Recalling firm: BioMerieux SA
Quantity: unknown

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

Code information

Reference no. 508650, Lot #1001060450, 1001154650, 1001212890, 1001264540, 1001319180, 1001390080, 1001390440, 1001409510, 1001409520, 1001441760, 1001540660, 1001589490, 1001621240 & 1001656460; Reference no. 508658, Lot #1001093880, 1001154820, 1001265110, 1001319480, 1001390570, 1001441910, 1001487610, 1001647880, 1001708510, 1001811360, 1002041010, 1002102920, 1002435570, 1002567240, 1002725010, 1003246020, 1003889730, 1004168400, 1004364330, 1004491220 & 1004939670; Reference no. 508610, Lot #1001026950, 1001199360 1001427690, 1001518090, 1001595490, 1001740320 & 1001989260 and Reference no. 508618, Lot #1001032350, 1001242030, 1001338050, 1001416820, 1001471720, 1001595500, 1001627650, 1001720440, 1001728140, 1001786480, 1001956220, 1002109250, 1002338880, 1002435190, 1002566960, 1002718380, 1002975330, 1003886270, 1003894060, 1003981160, 1004064990, 1004075190, 1004168390, 1004490810 & 1004939640.

Distribution pattern

Worldwide Distribution - U.S.( Nationwide); Foreign: Utd.Arab Emir., Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Russian, Fed. Sweden, Singapore, Thailand, Turkey, South Africa, Indonesia, Peru, Saudi Arabia, Gabon, Kazakhstan, Philippines, Ivory Coast, Venezuela, Kenya, Serbia, Tunisia, Macedonia, Lebanon, Romania, Benin, Bosnia-Herz., Oman, Uruguay, Lithuania, Burkina Faso, Slovenia, Qatar, Kuwait, Costa Rica, Paraguay, Dominican Republic, Croatia, Panama, Congo, Dem. Rep. Congo, Honduras, Estonia, Latvia, Cambodia, Bulgaria, Vietnam, Dutch Antilles, Nicaragua, Israel, Georgia, Palestine, Egypt, Pakistan (includ.Afghanistan), Malta, Jordan Bahrain, El Salvador, Nigeria, Dutch Antilles, Iran, Belarus, Zimbabwe, Morocco, Mauretania, Anguilla, Philippines, Malaysia, Turkmenistan, Guam, Brunei, Bolivia, Guatemala, Ecuador, Belarus, Mongolia

device · product 5 of 12

ETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 0.016-256. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions

Z-1525-2017

Recall number: Z-1525-2017
Initiated: December 15, 2016
Classification: Class II
Status: Terminated
Recalling firm: BioMerieux SA
Quantity: unknown

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

Code information

Reference no. 525550, Lot #1001094650, 1001136230, 1001212920, 1001293800, 1001302920, 1001319720, 1001334090, 1001391310, 1001430030, 1001518060 & 1001686190; Reference no. 525558, Lot #1001174720, 1001251340, 1001334100, 1001368020, 1001442000, 1001566840, 1001647970, 1001734920, 1001761450, 1001761480, 1001897000, 1001898600, 1002008040, 1002073480, 1002197270, 1002282890, 1002338820, 1002365880, 1002443950, 1002465840, 1002558040, 1002562240, 1002733640, 1002751340, 1003171920, 1003449250, 1003679000, 1003836080, 1004040220, 1004121870, 1004151340, 1004173130, 1004256780, 1004264340, 1004371500, 1004491190, 1004509340, 1004564470, 1004775890, 1004913990, 1004980270, 1005027170, 1005132320, 1005186480, 1004735790, 1004767430, 1004775900, 1004914010, 1004980280, 1005027180 & 1005132340; Reference no. 525510, Lot #1001051200, 1001125840, 1001416930, 1001455150, 1001548250 & 1001596090 and Reference no. 525518, Lot #1001192860, 1001223460, 1001317000, 1001338170, 1001416940, 1001416950, 1001492590, 1001566860, 1001634070, 1001728340, 1001761460, 1001887350, 1001894800, 1002007990, 1002045080, 1002113290, 1002197250, 1002287970, 1002338070, 1002369060, 1002440920, 1002463490, 1002496690, 1002565090, 1002583690, 1002604690, 1002663860, 1002809200, 1002809880, 1002876470, 1002922750, 1003079740, 1003134480, 1003373510, 1003621540, 1003778630, 1003809630, 1003910700, 1003972790, 1004052410, 1004121860, 1004150380, 1004256770, 1004371490, 1004496990, 1004508060, 1004564470, 1004775890, 1004913990, 1004980270, 1005027170, 1005132320 & 1005186480.

Distribution pattern

Worldwide Distribution - U.S.( Nationwide); Foreign: Utd.Arab Emir., Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Russian, Fed. Sweden, Singapore, Thailand, Turkey, South Africa, Indonesia, Peru, Saudi Arabia, Gabon, Kazakhstan, Philippines, Ivory Coast, Venezuela, Kenya, Serbia, Tunisia, Macedonia, Lebanon, Romania, Benin, Bosnia-Herz., Oman, Uruguay, Lithuania, Burkina Faso, Slovenia, Qatar, Kuwait, Costa Rica, Paraguay, Dominican Republic, Croatia, Panama, Congo, Dem. Rep. Congo, Honduras, Estonia, Latvia, Cambodia, Bulgaria, Vietnam, Dutch Antilles, Nicaragua, Israel, Georgia, Palestine, Egypt, Pakistan (includ.Afghanistan), Malta, Jordan Bahrain, El Salvador, Nigeria, Dutch Antilles, Iran, Belarus, Zimbabwe, Morocco, Mauretania, Anguilla, Philippines, Malaysia, Turkmenistan, Guam, Brunei, Bolivia, Guatemala, Ecuador, Belarus, Mongolia

device · product 6 of 12

ETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.002-32. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions

Z-1526-2017

Recall number: Z-1526-2017
Initiated: December 15, 2016
Classification: Class II
Status: Terminated
Recalling firm: BioMerieux SA
Quantity: unknown

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

Code information

Reference no. 535958, Lot #1004265390 & 1005138210 and Reference no. 535918, Lot #1003902400, 1004103780, 1004266960, 1004867770.

Distribution pattern

Worldwide Distribution - U.S.( Nationwide); Foreign: Utd.Arab Emir., Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Russian, Fed. Sweden, Singapore, Thailand, Turkey, South Africa, Indonesia, Peru, Saudi Arabia, Gabon, Kazakhstan, Philippines, Ivory Coast, Venezuela, Kenya, Serbia, Tunisia, Macedonia, Lebanon, Romania, Benin, Bosnia-Herz., Oman, Uruguay, Lithuania, Burkina Faso, Slovenia, Qatar, Kuwait, Costa Rica, Paraguay, Dominican Republic, Croatia, Panama, Congo, Dem. Rep. Congo, Honduras, Estonia, Latvia, Cambodia, Bulgaria, Vietnam, Dutch Antilles, Nicaragua, Israel, Georgia, Palestine, Egypt, Pakistan (includ.Afghanistan), Malta, Jordan Bahrain, El Salvador, Nigeria, Dutch Antilles, Iran, Belarus, Zimbabwe, Morocco, Mauretania, Anguilla, Philippines, Malaysia, Turkmenistan, Guam, Brunei, Bolivia, Guatemala, Ecuador, Belarus, Mongolia

device · product 7 of 12

ETEST Benzyl Penicillin PG256 FOAM packaging, Product Name: Etest Benzylpenicillin PG 0.016-256 (high). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions

Z-1527-2017

Recall number: Z-1527-2017
Initiated: December 15, 2016
Classification: Class II
Status: Terminated
Recalling firm: BioMerieux SA
Quantity: unknown

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

Code information

Reference no. 502558, Lot #1003036730, 1003142000, 1003191650, 1003408580, 1004047410, 1004139950, 1004242300, 1004539350, , 1004783810, 1004872380, 1004910650 & 1004985540 and Reference no. 502518, Lot #1002911350, 1002964350, 1003012790, 1004047370, 1004140000, 1004244180, 1004420440, 1004539950, 1004783760, 1004872350, 1004896600.

Distribution pattern

Worldwide Distribution - U.S.( Nationwide); Foreign: Utd.Arab Emir., Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Russian, Fed. Sweden, Singapore, Thailand, Turkey, South Africa, Indonesia, Peru, Saudi Arabia, Gabon, Kazakhstan, Philippines, Ivory Coast, Venezuela, Kenya, Serbia, Tunisia, Macedonia, Lebanon, Romania, Benin, Bosnia-Herz., Oman, Uruguay, Lithuania, Burkina Faso, Slovenia, Qatar, Kuwait, Costa Rica, Paraguay, Dominican Republic, Croatia, Panama, Congo, Dem. Rep. Congo, Honduras, Estonia, Latvia, Cambodia, Bulgaria, Vietnam, Dutch Antilles, Nicaragua, Israel, Georgia, Palestine, Egypt, Pakistan (includ.Afghanistan), Malta, Jordan Bahrain, El Salvador, Nigeria, Dutch Antilles, Iran, Belarus, Zimbabwe, Morocco, Mauretania, Anguilla, Philippines, Malaysia, Turkmenistan, Guam, Brunei, Bolivia, Guatemala, Ecuador, Belarus, Mongolia

device · product 8 of 12

ETEST Fosfomycin FM1024 Blister packaging, Product Name: ETEST Fosfomycin FM 0.064-1024. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions

Z-1528-2017

Recall number: Z-1528-2017
Initiated: December 15, 2016
Classification: Class II
Status: Terminated
Recalling firm: BioMerieux SA
Quantity: unknown

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

Code information

Reference no. 529140, Lot #1001390510, 1001441860, 1001609400, 1001733320, 1001761030, 1001920530, 1001966610, 1002009360, 1002084930, 1002106570, 1002158050, 1002168110, 1002395840, 1002452170, 1002500020, 1002604960, 1002992250, 1003030810, 1003127520, 1003274260, 1003322150, 1003412730, 1003535930, 1003678890, 1003800400, 1004100220, 1004177630, 1004365540, 1004410620, 1004557900, 1004703240, 1004783050, 1004838760, 1005034320, 1005097790, 1005151830; Reference no. 529148, Lot #1001368050, 1001442030, 1001566960, 1001578760, 1001708630, 1001833500, 1001894590, 1001920200, 1001955170, 1002084950, 1002172820, 1002226550, 1002410940, 1002451250, 1002501640, 1002604970, 1002964340, 1002992260, 1003121770, 1003274280, 1003491070, 1003526920, 1003626710, 1003743380, 1003946090, 1004037330, 1004273540, 1004323330, 1004557890, 1004593710, 1004696420, 1004790240, 1005031600, 1005098130, 1005151890 & 1005151920; Reference no. 529100, Lot #1001324170, 1001378120, 1001403920, 1001433710, 1001472010, 1001487340, 1001517680, 1001535750, 1001567600, 1001617880, 1001621170, 1001702730, 1001707190, 1001726300, 1001761020, 1001879240, 1001927370, 1001976740, 1001998470, 1002123080, 1002160660, 1002391350, 1002449230, 1002487920, 1002551790, 1002614480, 1002705810, 1002786510, 1002890670, 1002960380, 1002992220, 1003030800, 1003181900, 1003274090, 1003491050, 1003836110, 1004100080, 1004137920, 1004273550, 1004381380, 1004593700, 1004629890, 1004631880, 1004851860, 1005034300, 1005192380 & 1005261410 and Reference no. 529108, Lot #1001324180, 1001370190, 1001482570, 1001527650, 1001567610, 1001634260, 1001744620, 1001829580, 1002044710, 1002090510, 1002175950, 1002223920, 1002392160, 1002449900, 1002494590, 1002565460, 1002615530, 1002706050, 1002785800, 1002960400, 1002992240, 1003099530, 1003182230, 1003322130, 1003404520, 1003491000, 1003526910, 1003580860, 1003629820, 1003876820, 1004022140, 1004177620, 1004323320, 1004576570, 1004680780, 1004941770, 1005098120, 1005212770 & 1005302500.

Distribution pattern

Worldwide Distribution - U.S.( Nationwide); Foreign: Utd.Arab Emir., Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Russian, Fed. Sweden, Singapore, Thailand, Turkey, South Africa, Indonesia, Peru, Saudi Arabia, Gabon, Kazakhstan, Philippines, Ivory Coast, Venezuela, Kenya, Serbia, Tunisia, Macedonia, Lebanon, Romania, Benin, Bosnia-Herz., Oman, Uruguay, Lithuania, Burkina Faso, Slovenia, Qatar, Kuwait, Costa Rica, Paraguay, Dominican Republic, Croatia, Panama, Congo, Dem. Rep. Congo, Honduras, Estonia, Latvia, Cambodia, Bulgaria, Vietnam, Dutch Antilles, Nicaragua, Israel, Georgia, Palestine, Egypt, Pakistan (includ.Afghanistan), Malta, Jordan Bahrain, El Salvador, Nigeria, Dutch Antilles, Iran, Belarus, Zimbabwe, Morocco, Mauretania, Anguilla, Philippines, Malaysia, Turkmenistan, Guam, Brunei, Bolivia, Guatemala, Ecuador, Belarus, Mongolia

device · product 9 of 12

ETEST Imipenem IP32 Foam packaging, Product Name: ETEST Imipenem IP 0.002-32. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions

Z-1529-2017

Recall number: Z-1529-2017
Initiated: December 15, 2016
Classification: Class II
Status: Terminated
Recalling firm: BioMerieux SA
Quantity: unknown

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

Code information

Reference no. 513610, Lot #1001125240 & 1001610770; Reference no. 513618, Lot #1001193130, 1001223300, 1001316710, 1001377740, 1001454060, 1001454090, 1001527340, 1001633670, 1001721100, 1001801280, 1001804930, 1002029820, 1002234950, 1002238110, 1002269280, 1002476170, 1002593870, 1002699130, 1002702380 & 1003066070; Reference no. 513658, Lot #1001154880, 1001265150, 1001368000, 1001390590, 1001487630, 1001609830, 1001676400, 1001735190, 1001811380, 1002056670, 1002230910, 1002478800, 1002596830 & 1003066090 and Reference no. 513650, Lot #1001135740, 1001154700, 1001251110, 1001319240, 1001333960, 1001409550, 1001557360, 1001574370.

Distribution pattern

Worldwide Distribution - U.S.( Nationwide); Foreign: Utd.Arab Emir., Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Russian, Fed. Sweden, Singapore, Thailand, Turkey, South Africa, Indonesia, Peru, Saudi Arabia, Gabon, Kazakhstan, Philippines, Ivory Coast, Venezuela, Kenya, Serbia, Tunisia, Macedonia, Lebanon, Romania, Benin, Bosnia-Herz., Oman, Uruguay, Lithuania, Burkina Faso, Slovenia, Qatar, Kuwait, Costa Rica, Paraguay, Dominican Republic, Croatia, Panama, Congo, Dem. Rep. Congo, Honduras, Estonia, Latvia, Cambodia, Bulgaria, Vietnam, Dutch Antilles, Nicaragua, Israel, Georgia, Palestine, Egypt, Pakistan (includ.Afghanistan), Malta, Jordan Bahrain, El Salvador, Nigeria, Dutch Antilles, Iran, Belarus, Zimbabwe, Morocco, Mauretania, Anguilla, Philippines, Malaysia, Turkmenistan, Guam, Brunei, Bolivia, Guatemala, Ecuador, Belarus, Mongolia

device · product 10 of 12

ETEST Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM 0.016-256(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions

Z-1530-2017

Recall number: Z-1530-2017
Initiated: December 15, 2016
Classification: Class II
Status: Terminated
Recalling firm: BioMerieux SA
Quantity: unknown

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

Code information

Reference no. 512550, Lot # 1002001100 & 1002048740; Reference no. 512510, Lot #1001970170 & 1002154750; Reference no. 512558, Lot #1001564260, 1001676270, 1001733240, 1001793760, 1001873760, 1002113320, 1002230930, 1002559800, 1002823250, 1002113320, 1002230930, 1002559800, 1002823250, 1003495040, 1003883840, 1004248160, 1004252230, 1004277880, 1004567040, 1004946070, 1004980260, 1005146190, 1003495040, 1003883840, 1004248160, 1004252230, 1004277880, 1004567040, 1004946070, 1004980260 & 1005146190 and Reference no. 512518, Lot #1001595660, 1001707960, 1001803880, 1002094250, 1002229210, 1002233690, 1002559790, 1002684500, 1002823910, 1003164040, 1003191670, 1003279330, 1003604650, 1004047450, 1004157400, 1004247950, 1004252220, 1004528390 & 1004567000.

Distribution pattern

Worldwide Distribution - U.S.( Nationwide); Foreign: Utd.Arab Emir., Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Russian, Fed. Sweden, Singapore, Thailand, Turkey, South Africa, Indonesia, Peru, Saudi Arabia, Gabon, Kazakhstan, Philippines, Ivory Coast, Venezuela, Kenya, Serbia, Tunisia, Macedonia, Lebanon, Romania, Benin, Bosnia-Herz., Oman, Uruguay, Lithuania, Burkina Faso, Slovenia, Qatar, Kuwait, Costa Rica, Paraguay, Dominican Republic, Croatia, Panama, Congo, Dem. Rep. Congo, Honduras, Estonia, Latvia, Cambodia, Bulgaria, Vietnam, Dutch Antilles, Nicaragua, Israel, Georgia, Palestine, Egypt, Pakistan (includ.Afghanistan), Malta, Jordan Bahrain, El Salvador, Nigeria, Dutch Antilles, Iran, Belarus, Zimbabwe, Morocco, Mauretania, Anguilla, Philippines, Malaysia, Turkmenistan, Guam, Brunei, Bolivia, Guatemala, Ecuador, Belarus, Mongolia

device · product 11 of 12

ETEST Tobramycin TM256 FOAM packaging, Product Name: ETEST Tobramycin TM 0.016-256(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions

Z-1531-2017

Recall number: Z-1531-2017
Initiated: December 15, 2016
Classification: Class II
Status: Terminated
Recalling firm: BioMerieux SA
Quantity: unknown

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

Code information

Reference no. 522718, Lot #1001761650, 1002112440, 1002860460 & 1005166530 and Reference no. 522758, Lot #1001888970, 1002281590 & 1003590490.

Distribution pattern

Worldwide Distribution - U.S.( Nationwide); Foreign: Utd.Arab Emir., Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Russian, Fed. Sweden, Singapore, Thailand, Turkey, South Africa, Indonesia, Peru, Saudi Arabia, Gabon, Kazakhstan, Philippines, Ivory Coast, Venezuela, Kenya, Serbia, Tunisia, Macedonia, Lebanon, Romania, Benin, Bosnia-Herz., Oman, Uruguay, Lithuania, Burkina Faso, Slovenia, Qatar, Kuwait, Costa Rica, Paraguay, Dominican Republic, Croatia, Panama, Congo, Dem. Rep. Congo, Honduras, Estonia, Latvia, Cambodia, Bulgaria, Vietnam, Dutch Antilles, Nicaragua, Israel, Georgia, Palestine, Egypt, Pakistan (includ.Afghanistan), Malta, Jordan Bahrain, El Salvador, Nigeria, Dutch Antilles, Iran, Belarus, Zimbabwe, Morocco, Mauretania, Anguilla, Philippines, Malaysia, Turkmenistan, Guam, Brunei, Bolivia, Guatemala, Ecuador, Belarus, Mongolia

device · product 12 of 12

ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.002-32(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ¿g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in ¿g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions

Z-1532-2017

Recall number: Z-1532-2017
Initiated: December 15, 2016
Classification: Class II
Status: Terminated
Recalling firm: BioMerieux SA
Quantity: unknown

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

Code information

Reference no. 507058, Lot #1002940890, 1003128150, 1003361950, 1003849820, 1004041790, 1004239890, 1004395510, 1004525370, 1004756050, 1004828430, 1004876860, 1004919030 and Reference no. 507018, Lot #1002940880, 1003182290, 1003813700, 1003851130, 1003953490, 1004239880, 1004316460, 1004527210, 1004755930, 1004828450, 1004876850 & 1004919010.

Distribution pattern

Worldwide Distribution - U.S.( Nationwide); Foreign: Utd.Arab Emir., Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Russian, Fed. Sweden, Singapore, Thailand, Turkey, South Africa, Indonesia, Peru, Saudi Arabia, Gabon, Kazakhstan, Philippines, Ivory Coast, Venezuela, Kenya, Serbia, Tunisia, Macedonia, Lebanon, Romania, Benin, Bosnia-Herz., Oman, Uruguay, Lithuania, Burkina Faso, Slovenia, Qatar, Kuwait, Costa Rica, Paraguay, Dominican Republic, Croatia, Panama, Congo, Dem. Rep. Congo, Honduras, Estonia, Latvia, Cambodia, Bulgaria, Vietnam, Dutch Antilles, Nicaragua, Israel, Georgia, Palestine, Egypt, Pakistan (includ.Afghanistan), Malta, Jordan Bahrain, El Salvador, Nigeria, Dutch Antilles, Iran, Belarus, Zimbabwe, Morocco, Mauretania, Anguilla, Philippines, Malaysia, Turkmenistan, Guam, Brunei, Bolivia, Guatemala, Ecuador, Belarus, Mongolia

Event 76201

Event summary

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Every recalled product in this event

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