FDA Enforcement
Class II
Ongoing
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.
Recall: Z-1742-2020
·
Reported April 29, 2020
Enforcement
- Recall Number
- Z-1742-2020
- Event ID
- 85209
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Biomerieux Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 29, 2020
- Initiation Date
- March 11, 2020
- Classification Date
- April 17, 2020
- Address
- 595 Anglum Rd, N/A, Hazelwood, MO, 63042-2320, United States
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
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). .
Code Info
VITEK 2AST-P652 Test Kit with Catalog #421857 and Lot# 8021232403 Manufactured 11OCT2019, Expires 11APR2021
Distribution
No distribution within the United States. Foreign distribution locations: Netherlands, Luxembourg, Belgium
Quantity
1698 cartons (15,940 cards)