Biomerieux VITEK 2 Gram-positive Card Recall: False Positive Staphylococcus Risk
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.
Lower-risk recall
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). .
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/65663-biomerieux-vitek-2-gram-positive-card-recall-false-positive-staphylococcus.
Source Summary by GovInfoNow · govinfonow.com/recall/65663-biomerieux-vitek-2-gram-positive-card-recall-false-positive-staphylococcus · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1742-2020
Cite this page
“Biomerieux VITEK 2 Gram-positive Card Recall: False Positive Staphylococcus Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65663-biomerieux-vitek-2-gram-positive-card-recall-false-positive-staphylococcus. Based on FDA recall #Z-1742-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1742-2020%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
Check for the VITEK 2 AST-P652 Test Kit with Catalog #421857 and Lot# 8021232403. The product was manufactured on 11OCT2019 and expires 11APR2021.
- Brand
Biomerieux- Category
Medical device
What to do — step by step
Verify Test Results
Confirm that the test results are accurate by contacting Biomerieux or following their recommended verification process.
How this recall unfolded
Recall timeline
FDA published this recall 49 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using the product?
No, the recall does not require stopping use. Labs should verify results with the manufacturer to ensure accuracy.
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Where this comes from
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.
- Official source: FDA Recall #Z-1742-2020 (March 11, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1742-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.