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.
Reported: April 3, 2013 Initiated: February 6, 2013 #Z-1013-2013
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.
Details
- Recalling Firm
- Biomerieux Inc
- Units Affected
- 4/20-card cartons
- Distribution
- Distributed only in HI.
- Location
- Hazelwood, MO
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Biomerieux Inc. Units affected: 4/20-card cartons.
Why was this product recalled? ▼
The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 3, 2013. Severity: Moderate. Recall number: Z-1013-2013.
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