Z-1601-2015 Class II Terminated
FDA device recall Z-1601-2015 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: 1,025/20-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
- 1,025/20-card cartons
Product Description
Vitek 2 AST-YS06 REF 412 610, 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 286303720, expiration 08-APR-15
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1601-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026