Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-1603-2015

March 27, 2015

Class II

Product summary

Firm
Biomerieux Inc
Event
Event 70868
Status
Terminated
Classification
Class II
Quantity
1604/20-card cartons
Official record key
device-enforcement:Z-1603-2015

Official wording

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

Code information: lot 281317710, 26-AUG-15; lot 281347810, 22-JUN-16; and lot 281350120, 15-JUL-16.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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