medical MODERATE Updated 2017-03-01

BioMerieux SA recalls ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-4

Recalled 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

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Hazard / Issue

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

Issued by

FDA

Affected States: 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

Lot/Code Info: 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

✅ What Should You Do?

1Contact your healthcare provider immediately to discuss this recall.
2Stop using the device if it is safe to do so, and contact your provider.
3Follow the manufacturer's remedy instructions provided in the recall notice.
4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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View official government recall

BioMerieux SA recalls ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-4

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