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U.S. Department of Health and Human Services

Class 2 Device Recall Vitek 2 ASTYS07 REF 414 967

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  Class 2 Device Recall Vitek 2 ASTYS07 REF 414 967 see related information
Date Initiated by Firm March 27, 2015
Date Posted May 12, 2015
Recall Status1 Terminated 3 on March 24, 2017
Recall Number Z-1602-2015
Recall Event ID 70868
Product Classification Susceptibility test cards, antimicrobial - Product Code LTW
Product Vitek 2 AST-YS07 REF 414 967, Fungal 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 clinically significant yeasts to antifungal agents when used as instructed.
Code Information lot 287303120, 02-APR-15; lot 287303122, 02-APR-15; lot 287306710, 08-MAY-15; lot 287308210, 23-MAY-15; lot 287311710, 27-JUN-15; lot 287314910, 29-JUL-15; lot 287314912, 29-JUL-15; lot 287315710, 06-AUG-15; lot 287317310, 22-AUG-15; lot 287317710, 26-AUG-15; lot 287318920, 07-SEP-15; lot 287319110, 09-SEP-15; lot 287319820, 16-SEP-15; lot 287321940, 07-OCT-15; lot 287322540, 13-OCT-15; lot 287323520, 23-OCT-15; lot 287324220, 30-OCT-15; lot 287324240, 30-OCT-15; lot 287326220, 19-NOV-15; lot 287327620, 03-DEC-15; lot 287329620, 23-DEC-15; lot 287330520, 01-JAN-16; lot 287331920, 15-JAN-16; lot 287332520, 21-JAN-16; lot 287332522, 21-JAN-16; lot 287334810, 13-FEB-16; lot 287335420, 19-FEB-16; lot 287336220, 27-FEB-16; lot 287337620, 12-MAR-16; lot 287338020, 16-MAR-16; lot 287340140, 06-APR-16; lot 287341820, 23-APR-16; lot 287341822, 23-APR-16; lot 287344620, 21-MAY-16; lot 287344622, 21-MAY-16; lot 287346710, 11-JUN-16; lot 287346720, 11-JUN-16; lot 287350120, 15-JUL-16; and lot 287350122, 15-JUL-16.
Recalling Firm/
Manufacturer
Biomerieux Inc
595 Anglum Rd
Hazelwood MO 63042-2320
For Additional Information Contact Ryan LeMelle
314-731-8526
Manufacturer Reason
for Recall
The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258
FDA Determined
Cause 2
Other
Action The notification, consisting of the Field Safety Corrective Action (FSCA #2488) packet, was issued electronically to the subsidiaries and distributors on 3/27/15. FSCA #2509 was issued electronically to the subsidiaries and distributor on 4/13/15, which superseded FSCA #2488.
Quantity in Commerce 43,535/20-card cartons
Distribution Distributed only to foreign subsidiaries and distributors, including Canada and Mexico.
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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