FDA-Device2023-01-11Class II

VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829

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
58 units
Manufactured in
595 Anglum Rd, N/A, Hazelwood, MO, United States
Products
VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0861-2023

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