bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card — Class II medical device recall Z-1013-2013
Terminated recall by Biomerieux Inc, reported 2013-04-03. The product package did not contain the correct version of the package insert listing the limitations of use a
| Recall number | Z-1013-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomerieux Inc, Hazelwood, MO, United States |
| Recall initiated | 2013-02-06 |
| Classified | 2013-03-27 |
| Reported by FDA | 2013-04-03 |
| Terminated | 2013-10-30 |
| Lot numbers | 540274420 |
| Model numbers | 028, 410 |
Product
bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine the susceptibility of Streptococcus to antimicrobial agents.
Reason for recall
The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements.
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-1013-2013. 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.