bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine th
FDA device recall Z-1013-2013 · posted 2013-03-27 · Terminated
Recall details
- Recalling firm
- Biomerieux Inc
- Reason for recall
- The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements.
- Action taken
- bioMerieux sent an "PRODUCT SAFETY CORRECTION NOTICE" dated February 13, 2013 to the affected customer. The letter identified the product, problem, and actions to be taken by the customer. Contact the firm at (800) 682-2666 for questions regarding this notice.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- LTW
- Quantity affected
- 4/20-card cartons
- Distribution
- Distributed only in HI.
- Date initiated
- 2013-02-06
- Date posted
- 2013-03-27
- Date terminated
- 2013-10-30
- Location
- Hazelwood, MO
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