Recall Z-1013-2013— Biomerieux Inc
Class II · Terminated
Class II FDA medical device recall by Biomerieux Inc, initiated 2013-02-06, terminated 2013-10-30. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Biomerieux Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-02-06
- Terminated
- 2013-10-30
- Firm location
- Hazelwood, MO, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.