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Terminated

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.

FDA Recall Z-1603-2015 · Posted 2015-05-12

Recalling FirmBiomerieux Inc
Recall StatusTerminated
Product CodeLTW
Date Initiated2015-03-27
Date Terminated2017-03-24
Product Quantity1604/20-card cartons

Reason for Recall

The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258.

Firm 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 FSCA #2509 was issued electronically to the subsidiaries and distributor on 4/13/15, which superseded FSCA #2488.

Root Cause

Other

Distribution Pattern

Distributed only to foreign subsidiaries and distributors, including Canada and Mexico.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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