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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 Device Recall VITEK 2 ASTST01 Streptococcus Susceptibility Card see related information
Date Initiated by Firm February 06, 2013
Date Posted March 27, 2013
Recall Status1 Terminated 3 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 MO 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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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