FDA-Device2015-04-15Class III
Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.
Biomerieux Inc
Hazard
The outer carton label and package insert for the recalled product incorrectly lists Streptococcus pneumoniae as an organism for intended use.
Sold states
Worldwide Distribution to United Kingdom and Turkey. NO U.S. distribution.
Affected count
1505 cartons
Manufactured in
595 Anglum Rd, N/A, Hazelwood, MO, United States
Products
Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1403-2015Don't want to check this manually?
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