Z-1742-2020 Class II Ongoing
FDA device recall Z-1742-2020 was initiated by Biomerieux Inc on March 11, 2020 and is designated Class II. Reason for recall: There is a potential for the occurrence of false positive OXSF results for some Staphylococcus aureus strains in conjunction with the VITEK 2 AST-P652 test card (ref. 421857, lot 8021232403). . The recall status is ongoing. Affected quantity: 1698 cartons (15,940 cards).
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2020
- Initiation Date
- March 11, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1698 cartons (15,940 cards)
Product Description
The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test to determine susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed.
Reason for Recall
There is a potential for the occurrence of false positive OXSF results for some Staphylococcus aureus strains in conjunction with the VITEK 2 AST-P652 test card (ref. 421857, lot 8021232403). .
Distribution Pattern
No distribution within the United States. Foreign distribution locations: Netherlands, Luxembourg, Belgium
Code Information
VITEK 2AST-P652 Test Kit with Catalog #421857 and Lot# 8021232403 Manufactured 11OCT2019, Expires 11APR2021