FDA Device recall Z-1013-2013
bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028
- FDA Device
- Class II
- terminated
- Published 2013-04-03
On 2013-04-03 the FDA classified a Class II recall of bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028 by Biomerieux, citing the product package did not contain the correct version of the package insert listing the limitations of use and performance requirements.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1013-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-06 |
| Published | 2013-04-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomerieux |
| Distribution | HI |
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
The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements.
Identifiers
| code_info | lot number: 540274420 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1013-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.