Z-1641-2016 Class I Terminated
FDA device recall Z-1641-2016 was initiated by Biomerieux Inc on Feb 24, 2016 and is designated Class I. Reason for recall: Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin. The recall status is terminated (terminated Mar 8, 2018). Affected quantity: 7,497 kits.
Recall Details
- Product Type
- Devices
- Report Date
- May 18, 2016
- Initiation Date
- Feb 24, 2016
- Termination Date
- Mar 8, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,497 kits
Product Description
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.
Reason for Recall
Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
Distribution Pattern
Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.
Code Information
Lots 740340920 exp. 4/14/16, 740350820 exp. 7/22/16, 740356320 exp. 9/15/16, 740361110 exp. 11/2/16, 740371720 exp. 2/16/17, 740386420 exp. 7/13/17, and 740388520 exp. 8/3/17.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1641-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026