The VITEK 2 Gram-positive Susceptibility Card is intended for use… — Class II medical device recall Z-1742-2020
Ongoing recall by Biomerieux Inc, reported 2020-04-29. There is a potential for the occurrence of false positive OXSF results for some Staphylococcus aureus strains
| Recall number | Z-1742-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomerieux Inc, Hazelwood, MO, United States |
| Recall initiated | 2020-03-11 |
| Classified | 2020-04-17 |
| Reported by FDA | 2020-04-29 |
| Countries outside the US | BE, LU, NL |
| Pathogens | staphylococcus |
| Lot numbers | 8021232403 |
| Model numbers | 421857 |
| Expiration dates | 2021-04-11 |
Product
The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test to determine susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed.
Reason for 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). .
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1742-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.