FDA-Device2023-01-11Class II

VITEK 2 REAGENT AST-GN95 TEST KIT 20 CARDS, CATALOG 421982

Biomerieux Inc
Hazard

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Sold states
US Nationwide distribution.
Affected count
84 units
Manufactured in
595 Anglum Rd, N/A, Hazelwood, MO, United States
Products
VITEK 2 REAGENT AST-GN95 TEST KIT 20 CARDS, CATALOG 421982

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0853-2023

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