Device 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.
Z-1013-2013
Product summary
- Firm
- Biomerieux Inc
- Event
- Event 64327
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4/20-card cartons
- Official record key
device-enforcement:Z-1013-2013
Official wording
Reason: The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements.
Code information: lot number: 540274420
Distribution pattern: Distributed only in HI.
Derived failure modes
-
Unknown
The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements.