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Recall Observatory FDA recall evidence

Device product

ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305 ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacterial such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria

Z-1226-2017

January 18, 2017

Class II

Product summary

Firm
BioMerieux SA
Event
Event 76329
Status
Terminated
Classification
Class II
Quantity
7,160 units
Official record key
device-enforcement:Z-1226-2017

Official wording

Reason: Potential performance issues. False Susceptible result instead of Intermediate and False Intermediate result with certain methods.

Code information: REF 412304 - 1004497830; REF 412305 - 1002884720, 1003028270, 1003075500, 1003383650, 1004018820, 1004497810, 1005161160; REF 506918 - 1002884980, 1003028290, 1003075850, 1003385930, 1003396150, 1004022170, 1004498100, 1005161470; REF 506958 - 1002885010, 1003075540, 103396550, 1004019050, 1004501930, 1005161480

Distribution pattern: Worldwide Distribution - US including AZ, AR, CA, CT, DE, DC, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MS, MO, NE, NH, NJ, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WV, WI, and Internationally to Algeria, United Arab Emirates, Austria, Australia, Brazil, Cambodia, Canada, Chile, Chine, Costa Rica, Croatia, Czech Republic, Ecuador, Estonia, France, Greece, Germany, Great Britain, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Luxembourg, Malaysia, Netherlands, Nigeria, Norway, Oman, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russia, San Marino, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, Uruguay, and Vietnam

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential performance issues. False Susceptible result instead of Intermediate and False Intermediate result with certain methods.