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.
- Company
- Biomerieux Inc
- Recall Initiated
- March 11, 2020
- Recall Number
- Z-1742-2020
- Quantity
- 1698 cartons (15,940 cards)
- Firm Location
- Hazelwood, MO
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
No distribution within the United States. Foreign distribution locations: Netherlands, Luxembourg, Belgium
Lot / Code Info
VITEK 2AST-P652 Test Kit with Catalog #421857 and Lot# 8021232403 Manufactured 11OCT2019, Expires 11APR2021
Root Cause
Under Investigation by firm
Action Taken
On March, 11, 2020 a notification letter was issued to the impacted subsidiaries which included a Customer Letter to be translated into local language. The customer letter instructs the customer to stop the use of the impacted AST-P652 lot, to complete the attached Acknowledgement Form, and return any affected unused product to their local bioMrieux representative as soon as possible.