Z-1401-2015 Class III Terminated
FDA device recall Z-1401-2015 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: 10409 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
- 10409 cartons
Product Description
Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container, 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 735352820, expiration 11AUG16; lot 735348620, expiration 30JUN16; lot 735346520, expiration 09JUN16; lot 735342320; expiration 28APR16; lot 735318020, expiration 29AUG15; lot 735315920, expiration 08AUG15; lot 735323710, expiration 25OCT15; lot 735310210, expiration 12JUN15
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1401-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026