FDA-Device2020-04-29Class II
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.
Biomerieux Inc
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). .
Sold states
No distribution within the United States. Foreign distribution locations: Netherlands, Luxembourg, Belgium
Affected count
1698 cartons (15,940 cards)
Manufactured in
595 Anglum Rd, N/A, Hazelwood, MO, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1742-2020Don't want to check this manually?
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