FDA-Device2023-01-11Class II
ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016
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
5 units
Manufactured in
595 Anglum Rd, N/A, Hazelwood, MO, United States
Products
ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0812-2023Don't want to check this manually?
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