Z-1643-2016 Class I Terminated
FDA device recall Z-1643-2016 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: 15,006 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
- 15,006 kits
Product Description
Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 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 742343610 exp. 5/11/16, 742347220 exp. 6/16/16, 742350010 exp. 7/14/16, 742352820 exp. 8/11/16, 742355710 exp. 9/9/16, 742362540 exp. 11/16/16, 742364020 exp. 12/1/16, 742368210 exp. 1/12/16, 742376540 exp. 4/5/17, 742383610 exp. 6/15/17, and 742389220 exp. 8/10/17.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1643-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026