FDAFDA · Food and drugs·Recall number Z-1742-2020
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.
Published April 29, 2020 · Recall initiated: March 11, 2020
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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). .
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomerieux Inc
- Distributor
- No distribution within the United States. Foreign distribution locations: Netherlands, Luxembourg, Belgium
- Lot
- VITEK 2AST-P652 Test Kit with Catalog #421857 and Lot# 8021232403 Manufactured 11OCT2019, Expires 11APR2021
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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