Z-1403-2015 Class III Terminated
FDA device recall Z-1403-2015 was initiated by Biomerieux Inc on Feb 25, 2015 and is designated Class III. Reason for recall: The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use. The recall status is terminated (terminated Mar 22, 2017). Affected quantity: 1505 cartons.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 15, 2015
- Initiation Date
- Feb 25, 2015
- Termination Date
- Mar 22, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1505 cartons
Product Description
Vitek 2 AST-P641 REF 418 590 Gram Positive 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 Staphylococcus spp., Enterococcus spp., and S. agalactiae.
Reason for Recall
The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use.
Distribution Pattern
Worldwide Distribution to United Kingdom and Turkey. NO U.S. distribution.
Code Information
lot 741350820, expiration 22JUL16; lot 741340920, expiration 14APR16;
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1403-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026