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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

BioMerieux SA: 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.

Agency Publication Date: December 19, 2017
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Affected Products

Product: ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.

REF: 520558, Lot numbers: 1003059010, 1003315830, 1004071250, 1004818860 and 1004890400.

Lot Numbers:
numbers
Product: ETEST OXACILLIN OX 256 WW F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.

REF: 520518, Lot numbers: 1003055340, 1003315740, 1004070580, 1004319590, 1004818850, 1004890270 and 1005366110.

Lot Numbers:
numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78688
Status: Resolved
Manufacturer: BioMerieux SA
Manufactured In: France
Units Affected: 2 products (1585 units)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.