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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 Cardsee related information
Date Initiated by FirmFebruary 06, 2013
Date PostedMarch 27, 2013
Recall Status1 Terminated 3 on October 30, 2013
Recall NumberZ-1013-2013
Recall Event ID 64327
Product Classification Susceptibility test cards, antimicrobial - Product Code LTW
ProductbioMerieux 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
FEI Number 1950204
Recalling Firm/
Manufacturer		 Biomerieux Inc
595 Anglum Rd
Hazelwood MO 63042-2320
For Additional Information ContactRyan 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
ActionbioMerieux 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 Commerce4/20-card cartons
DistributionDistributed only in HI.
Total Product Life CycleTPLC 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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