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U.S. Department of Health and Human Services

Class 2 Device Recall VITEK TWO ASTN085 REF 22 225

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  Class 2 Device Recall VITEK TWO ASTN085 REF 22 225 see related information
Date Initiated by Firm July 29, 2010
Date Posted August 27, 2010
Recall Status1 Terminated 3 on November 02, 2010
Recall Number Z-2295-2010
Recall Event ID 56365
Product Classification System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
Product VITEK TWO AST-N085 REF 22 225 For In Vitro Diagnostic Use - each test card is packaged into a foil pouch with 20 pouches per box. The firm name on the label is bioMerieux, Inc., Durham, NC and bioMerieux, sa, France.This is an Export Only test kit that is not marketed in the U.S.
Code Information Lot number 345158910 Exp:2011/04/21
Recalling Firm/
Manufacturer
Biomerieux Inc
595 Anglum Rd
Hazelwood MO 63042
For Additional Information Contact Benjamin Smith
314-731-8667
Manufacturer Reason
for Recall
Foil pouch was punctured by drug susceptibility cards during packaging, allowing moisture into pouch, resulting in inaccurate and/or incorrect drug susceptibility results.
FDA Determined
Cause 2
Packaging
Action BioMerieux issued an Urgent Product Removal Notice, dated July 29, 2010 to consignees, identifying the reason for the recall and the affected lots. Customers were instructed to discontinue use of and destroy any remaining inventory of the affected lot, and to notify their customers who received the product. All consignees were instructed to complete and return the Customer Acknowledgement and Product Replacement Form. These cards will be used to distribute replacement cards. Consignees can contact BioMerieux at 1-314- 731-8667.
Quantity in Commerce 1297/ 20 card boxes
Distribution Worldwide Distribution: Country of Canada only. No product was distributed in the US.
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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