Reported Dec 27, 2017 · Terminated

ETEST OXACILLIN OX 256 WW F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial…

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

Is this the product you have?

  • ETEST OXACILLIN OX 256 WW F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.
Lot codes and dates
  • REF520518
  • Lot numbers
    • 1003055340
    • 1003315740
    • 1004070580
    • 1004319590
    • 1004818850
    • 1004890270 and 1005366110
Amount recalled
1585 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide
  • GA

Why it was recalled

QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Foam packaging (Ref. 520558, 520518) reported. The product behavior could lead to False Resistant results.

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 Aug 18, 2020 · Data as of Sep 19, 6:07 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.