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U.S. Department of Health and Human Services

Class 2 Device Recall Vitek 2 ASTYS06 REF 412 610

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  Class 2 Device Recall Vitek 2 ASTYS06 REF 412 610 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-1601-2015
Recall Event ID 70868
Product Classification Susceptibility test cards, antimicrobial - Product Code LTW
Product Vitek 2 AST-YS06 REF 412 610, 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 286303720, expiration 08-APR-15
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 FSCA #2509 was issued electronically to the subsidiaries and distributor on 4/13/15, which superseded FSCA #2488.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 1,025/20-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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