Date Initiated by Firm | March 27, 2015 |
Date Posted | May 12, 2015 |
Recall Status1 |
Terminated 3 on March 24, 2017 |
Recall Number | Z-1603-2015 |
Recall Event ID |
70868 |
Product Classification |
Susceptibility test cards, antimicrobial - Product Code LTW
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Product | Vitek 2 AST-YS01 REF 22 108, 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 281317710, 26-AUG-15; lot 281347810, 22-JUN-16; and lot 281350120, 15-JUL-16. |
Recalling Firm/ Manufacturer |
Biomerieux Inc 595 Anglum Rd Hazelwood MO 63042-2320
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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 FSCA #2509 was issued electronically to the subsidiaries and distributor on 4/13/15, which superseded FSCA #2488.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 | 1604/20-card cartons |
Distribution | Distributed only to foreign subsidiaries and distributors, including Canada and Mexico. |
Total Product Life Cycle | TPLC Device Report |
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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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