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U.S. Department of Health and Human Services

Class 3 Device Recall Vitek 2 ASTP641 REF 418 590

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 Class 3 Device Recall Vitek 2 ASTP641 REF 418 590see related information
Date Initiated by FirmFebruary 25, 2015
Date PostedApril 08, 2015
Recall Status1 Terminated 3 on March 22, 2017
Recall NumberZ-1403-2015
Recall Event ID 70645
Product Classification Susceptibility test cards, antimicrobial - Product Code LTW
ProductVitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.
Code Information lot 741350820, expiration 22JUL16; lot 741340920, expiration 14APR16;
Recalling Firm/
Manufacturer		 Biomerieux Inc
595 Anglum Rd
Hazelwood MO 63042-2320
For Additional Information ContactRyan LeMelle
314-731-8526
Manufacturer Reason
for Recall		The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use.
FDA Determined
Cause 2		Employee error
ActionBiomerieux, Incs sent an Urgent Product Correction Notice on February 25, 2015, to all affected customers. The letter identified the product, the problem, and the actions to be taken by the customer. Customers were instructed to do the following: " Please confirm this letter has been distributed and reviewed by all appropriate personnel within your organization. " For the referenced test kits (VITEK 2 ASTP635, ASTP640 or ASTP641), review the claimed organisms in the Package Insert antibiotic table to confirm which organisms can be tested. " Refrain from using the referenced test kits to determine the susceptibility of Streptococcus pneumoniae. " Reference your Laboratory Standard Operating Procedures to identify card type used for specific organisms. " Please store this letter with your bioMrieux instrument documentation. Please complete the attached Acknowledgement Form and return it to bioMrieux, Inc. Customers with questions were instructed to contact their local BioMerieux representative. For questions regarding this recall call 314-731-8526.
Quantity in Commerce1505 cartons
DistributionWorldwide Distribution to United Kingdom and Turkey. NO U.S. distribution.
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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