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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88137

6 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 30, 2020
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Luminex Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024

Z-2006-2021
Recall number
Z-2006-2021
Initiated
October 30, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Luminex Corporation
Quantity
38,990

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for a false-negative result.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for a false-negative result.

Code information

030520024A, 030720024A, 031020024A, 031120024A, 031320024A, 031620024C, 031820024A, 031920024A, 032120024A, 032320024A, 032420024A, 032620024A, 033120024A, 040220024A, 040320024A, 040420024A, 040620024A, 040720024A, 040920024A, 041120024A, 041420024A, 041620024A, 041820024A, 042020024A, 042120024A, 042320024A, 042520024A, 060320024A, 061320024A, 062320024A, 070820024A, 071020024A, 072120024A, 072920024A, 080720024A, 081920024A and 091120024A

Distribution pattern

Worldwide distribution - US Nationwide including in the states of AL, AZ, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA and VT. The countries of Austria, Chile, France, Germany, Greece, Italy, Japan, Kuwait, Netherlands, Spain, Thailand, Turkey, and United Kingdom.

device · product 2 of 6

Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018

Z-2007-2021
Recall number
Z-2007-2021
Initiated
October 30, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Luminex Corporation
Quantity
36,416

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for a false-negative result.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for a false-negative result.

Code information

030620018A, 031420018A, 032020018A, 040120018A, 041020018B, 041720018B, 042420018A, 043020018A, 050220018A, 050720018A, 050920018A, 051320018A, 051420018A, 051520018A, 052020018A,052120018A, 052920018A, 060220018A, 060920018A, 061020018A, 061620018A, 061920018D, 062020018A, 062620018A, 063020018A, 070720018A, 071620018A, 072320018A, 073020018A, 080520018A, 082020018A, 082520018A, 082820018A, and 090120018A

Distribution pattern

Worldwide distribution - US Nationwide including in the states of AL, AZ, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA and VT. The countries of Austria, Chile, France, Germany, Greece, Italy, Japan, Kuwait, Netherlands, Spain, Thailand, Turkey, and United Kingdom.

device · product 3 of 6

Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021

Z-2008-2021
Recall number
Z-2008-2021
Initiated
October 30, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Luminex Corporation
Quantity
17,110

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for a false-negative result.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for a false-negative result.

Code information

030320021B, 031220021A, 032720021B, 040820021A, 041020021A, 041720021A, 042220021A, 042920021A, 050520021A, 051220021A, 051920021A, 053020021A, 060520021A, 061220021A, 061720021A, 070120021A, 072420021A, 081820021B, and 082620021A

Distribution pattern

Worldwide distribution - US Nationwide including in the states of AL, AZ, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA and VT. The countries of Austria, Chile, France, Germany, Greece, Italy, Japan, Kuwait, Netherlands, Spain, Thailand, Turkey, and United Kingdom.

device · product 4 of 6

Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023

Z-2009-2021
Recall number
Z-2009-2021
Initiated
October 30, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Luminex Corporation
Quantity
24,338

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for a false-negative result.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for a false-negative result.

Code information

030420023A, 031720023A, 032520023A, 040820023B, 041520023B, 042220023B, 042820023A, 050120023A, 050620023B, 050820023B, 052720023A, 052820023A, 060420023A, 060620023A, 061120023A, 061820023A, 062520023A, 062720023A, 070220023A, 070920023A, 071420023A, 071720023A, 072820023A, 080420023A, and 090920023A

Distribution pattern

Worldwide distribution - US Nationwide including in the states of AL, AZ, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA and VT. The countries of Austria, Chile, France, Germany, Greece, Italy, Japan, Kuwait, Netherlands, Spain, Thailand, Turkey, and United Kingdom.

device · product 5 of 6

Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022

Z-2010-2021
Recall number
Z-2010-2021
Initiated
October 30, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Luminex Corporation
Quantity
1,261

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for a false-negative result.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for a false-negative result.

Code information

041520022A, 061920022A, and 081120022A

Distribution pattern

Worldwide distribution - US Nationwide including in the states of AL, AZ, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA and VT. The countries of Austria, Chile, France, Germany, Greece, Italy, Japan, Kuwait, Netherlands, Spain, Thailand, Turkey, and United Kingdom.

device · product 6 of 6

Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026

Z-2011-2021
Recall number
Z-2011-2021
Initiated
October 30, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Luminex Corporation
Quantity
165

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for a false-negative result.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for a false-negative result.

Code information

050620026A and 072120026B,

Distribution pattern

Worldwide distribution - US Nationwide including in the states of AL, AZ, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA and VT. The countries of Austria, Chile, France, Germany, Greece, Italy, Japan, Kuwait, Netherlands, Spain, Thailand, Turkey, and United Kingdom.