Z-1013-2013 Class II Terminated
FDA device recall Z-1013-2013 was initiated by Biomerieux Inc on Feb 6, 2013 and is designated Class II. Reason for recall: The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements. The recall status is terminated (terminated Oct 30, 2013). Affected quantity: 4/20-card cartons.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 3, 2013
- Initiation Date
- Feb 6, 2013
- Termination Date
- Oct 30, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4/20-card cartons
Product Description
bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine the susceptibility of Streptococcus to antimicrobial agents.
Reason for Recall
The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements.
Distribution Pattern
Distributed only in HI.
Code Information
lot number: 540274420
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1013-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026