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.
This recall is currently active, issued March 11, 2020. It was issued by Biomerieux Inc.
- Company
- Biomerieux Inc
- Recall Initiated
- March 11, 2020
- Recall Number
- Z-1742-2020
- Quantity
- 1698 cartons (15,940 cards)
- Firm Location
- Hazelwood, MO
- Official Source
- View on FDA website ↗
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.