Biomerieux recalls VITEK 2 Gram-positive Susceptibility Cards (lot 8021232403) due to potential false positive OXSF results for Staphylococcus aureus strains. Affected labs should verify test results with the manufacturer.
There is a potential for the occurrence of false positive OXSF results for some Staphylococcus aureus strains in conjunction with the VITEK 2 AST-P652 test card (ref. 421857, lot 8021232403). .
Biomerieux recalls specific VITEK 2 Gram-positive Susceptibility Cards used in clinical labs for false positive results with Staphylococcus aureus. This could lead to incorrect antibiotic treatment decisions if not addressed.
The card may produce false positive OXSF results for certain Staphylococcus aureus strains when used with the VITEK 2 AST-P652 test. This could lead to incorrect antibiotic treatment decisions if the false result is not recognized.
Clinical laboratory users who have the VITEK 2 AST-P652 Test Kit with Catalog #421857 and Lot# 8021232403. Labs using this specific card for Staphylococcus testing are most at risk.
Check for the VITEK 2 AST-P652 Test Kit with Catalog #421857 and Lot# 8021232403. The product was manufactured on 11OCT2019 and expires 11APR2021.
Confirm that the test results are accurate by contacting Biomerieux or following their recommended verification process.
The recall specifically affects the VITEK 2 AST-P652 Test Kit with Catalog #421857 and Lot# 8021232403. If you have this exact lot, you should verify results.
Look for the VITEK 2 AST-P652 Test Kit with Catalog #421857 and Lot# 8021232403. The product was manufactured on 11OCT2019 and expires 11APR2021.
No, the recall does not require stopping use. Labs should verify results with the manufacturer to ensure accuracy.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-1742-2020 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-1742-2020 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.
