BioMérieux recalls VITEK 2 AST-P655 test cards with insufficient gentamicin due to manufacturing error. Affected lots may produce inaccurate test results for bacterial susceptibility.
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).
BioMérieux is recalling specific lots of VITEK 2 AST-P655 bacterial test cards because they contain less gentamicin than required. This could lead to inaccurate test results for certain bacteria, potentially affecting medical treatment decisions.
The test cards were manufactured with less gentamicin than required for the Gentamicin High-Level Resistance (ghlr01n) screen test due to an error in preparing media solutions. This could cause the test to show false resistance or sensitivity results for certain bacteria.
Laboratories using the VITEK 2 AST-P655 test cards for bacterial susceptibility testing are affected. Those testing Staphylococcus, Enterococcus, or Streptococcus agalactiae with gentamicin may be at risk of inaccurate results.
Check if your VITEK 2 AST-P655 test cards have lot numbers 8050348103, 8050452403, 8050655403, or 8050690403. These cards were sold for bacterial susceptibility testing in laboratories.
Verify if your VITEK 2 AST-P655 test cards have the affected lot numbers: 8050348103, 8050452403, 8050655403, or 8050690403.
Routine internal review of Device History Records identified six VITEK 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.
Check if your VITEK 2 AST-P655 test cards have the affected lot numbers: 8050348103, 8050452403, 8050655403, or 8050690403. If so, contact BioMérieux for guidance.
Yes, the test cards may produce inaccurate results for bacterial susceptibility testing of Staphylococcus, Enterococcus, or Streptococcus agalactiae, which could impact treatment decisions.
We’ve drafted a message you can send BioMérieux to request your refund or repair — edit it as you like.
Subject: Recall Z-3180-2018 — BioMérieux BioMérieux Hello, I own a BioMérieux that is covered by recall Z-3180-2018 from BioMérieux. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
