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U.S. Department of Health and Human Services

Class 2 Device Recall VITEK 2 ASTST01 Streptococcus Susceptibility Card

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 Class 2 Recall
VITEK 2 ASTST01 Streptococcus Susceptibility Card
see related information
Date Posted March 27, 2013
Recall Status1 Terminated on October 30, 2013
Recall Number Z-1013-2013
Recall Event ID 64327
Product Classification Susceptibility Test Cards, Antimicrobial - Product Code LTW
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.
Code Information lot number: 540274420
Recalling Firm/
Manufacturer
Biomerieux Inc
595 Anglum Rd
Hazelwood, Missouri 63042-2320
For Additional Information Contact Ryan LeMelle
314-731-8522
Manufacturer Reason
for Recall
The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Error in Labeling
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.
Quantity in Commerce 4/20-card cartons
Distribution Distributed only in HI.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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