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U.S. Department of Health and Human Services

Class 1 Device Recall VITEK 2 Gram Positive Susceptibility Test Cards

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  Class 1 Device Recall VITEK 2 Gram Positive Susceptibility Test Cards see related information
Date Initiated by Firm February 24, 2016
Date Posted May 11, 2016
Recall Status1 Terminated 3 on March 08, 2018
Recall Number Z-1642-2016
Recall Event ID 73413
Product Classification Susceptibility test cards, antimicrobial - Product Code LTW
Product Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 REF 418590), 20 cards/kit.

Product Usage:
The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
Code Information Lots 741340920 exp. 4/14/16, 741350820 exp. 7/22/16, 741356320 exp. 9/15/16, 741357020 exp. 9/22/16, and 741366820 exp. 12/29/16.
Recalling Firm/
Manufacturer		 Biomerieux Inc
595 Anglum Rd
Hazelwood MO 63042-2320
For Additional Information Contact Jeff Scanlan
314-731-8526
Manufacturer Reason
for Recall		 Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
FDA Determined
Cause 2		 Labeling Change Control
Action Biomerieux sent an Urgent Product Correction Notice letter via email on February 24, 2016 to affected customers . The letter identified the affected product, problem and actions to be taken. Customers were asked to complete the attached Acknowledgement Form (Attachment A) and return it to Biomerieux, Inc. For questions contact your local bioM¿rieux representative.
Quantity in Commerce 3,594 kits
Distribution Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.
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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