Z-1603-2015 Class II Terminated
FDA device recall Z-1603-2015 was initiated by Biomerieux Inc on Mar 27, 2015 and is designated Class II. Reason for recall: The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258. The recall status is terminated (terminated Mar 24, 2017). Affected quantity: 1604/20-card cartons.
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2015
- Initiation Date
- Mar 27, 2015
- Termination Date
- Mar 24, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1604/20-card cartons
Product Description
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 for Recall
The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258.
Distribution Pattern
Distributed only to foreign subsidiaries and distributors, including Canada and Mexico.
Code Information
lot 281317710, 26-AUG-15; lot 281347810, 22-JUN-16; and lot 281350120, 15-JUL-16.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1603-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026