bioMerieux recalls VITEK 2 AST-P640 test cards with incorrect gentamicin dosage, potentially affecting Staphylococcus and Enterococcus testing accuracy. Affected lots include 7400410103 and 7400697403.
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).
bioMerieux recalls specific lots of VITEK 2 AST-P640 test cards that were manufactured with less gentamicin than required. This could lead to inaccurate test results for Staphylococcus and Enterococcus bacteria, which may impact medical treatment decisions.
The test cards were made with less gentamicin than required for the Gentamicin High-Level Resistance (ghlr01n) screen test. This error occurred during media well preparation for 1500mL and 2000mL solutions, potentially causing inaccurate test results.
Laboratories using the VITEK 2 AST-P640 test cards for bacterial susceptibility testing are affected. Those testing Staphylococcus, Enterococcus, or Streptococcus agalactiae may be at risk of inaccurate results.
Check if your VITEK 2 AST-P640 test cards have lot numbers 7400410103 or 7400697403. These cards are used for bacterial susceptibility testing of Staphylococcus, Enterococcus, and Streptococcus agalactiae.
Verify if your VITEK 2 AST-P640 test cards have lot numbers 7400410103 or 7400697403.
The test cards were manufactured with less gentamicin than required for the Gentamicin High-Level Resistance (ghlr01n) screen test, which could lead to inaccurate test results for Staphylococcus and Enterococcus bacteria.
Labs using the VITEK 2 AST-P640 test cards for bacterial susceptibility testing of Staphylococcus, Enterococcus, and Streptococcus agalactiae are affected.
Check if your VITEK 2 AST-P640 test cards have lot numbers 7400410103 or 7400697403. If so, contact bioMerieux for guidance.
We’ve drafted a message you can send bioMerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-3179-2018 — bioMerieux bioMerieux Hello, I own a bioMerieux that is covered by recall Z-3179-2018 from bioMerieux. 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.
