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.
FDA Recall Z-1013-2013 · Posted 2013-03-27
Recalling FirmBiomerieux Inc
Recall StatusTerminated
Product CodeLTW
Date Initiated2013-02-06
Date Terminated2013-10-30
Product Quantity4/20-card cartons
Reason for Recall
The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements.
Firm Action
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
Distribution Pattern
Distributed only in HI.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.