Device Recall Vitek 2 ASTYS01 REF 22 108

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

Immunology and Microbiology Devices

2

No

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

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.