FDA Device recall Z-1603-2015
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 la…
- FDA Device
- Class II
- terminated
- Published 2015-05-20
On 2015-05-20 the FDA classified a Class II recall of 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 la… by Biomerieux, citing the test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1603-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-27 |
| Published | 2015-05-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomerieux |
| Distribution | n/a |
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.
Reason
The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258.
Identifiers
| code_info | lot 281317710, 26-AUG-15; lot 281347810, 22-JUN-16; and lot 281350120, 15-JUL-16. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1603-2015%22
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