VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobial...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-3179-2018.
Routine internal review of Device History Records identified six VITEK(R) 2 AST card lots were manufactured with less drug (gentamicin) than required for the Gentamicin High-Level Resistance (ghlr01n) screen test due to an error when making 1500mL and 2000mL media well preparations (solutions).
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-3179-2018.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Biomerieux, Inc. or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-3179-2018.
bioMerieux, Inc.
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Biomerieux, Inc. Recall FAQ
Biomerieux, Inc. is the subject of a medical implants safety report: VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobial.... The notice was published on August 13, 2018 by the U.S. Food and Drug Administration (FDA). Approximately 2,538 units are potentially affected.