Reported Mar 1, 2017 · Terminated

ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305 ETEST is a quantitative technique for determining the…

BioMerieux SA

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: BioMerieux SA · Chemin De L'Orme · Marcy L'Etoile, N/A · N/A

Is this the product you have?

  • ETEST XM256 (Cefuroxime)
  • Foam506958-506918
  • SPB412304-412305 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
Lot codes and dates

4 of 4 products

Products covered by this recall
Model / numberProduct as published
4123041004497830
4123051002884720, 1003028270, 1003075500, 1003383650, 1004018820, 1004497810, 1005161160
5069181002884980, 1003028290, 1003075850, 1003385930, 1003396150, 1004022170, 1004498100, 1005161470
5069581002885010, 1003075540, 103396550, 1004019050, 1004501930, 1005161480
Amount recalled
7,160 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 30, 2020 · Data as of Sep 19, 6:49 PM UTC

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