FDA recall Z-0848-2023
Biomerieux Inc · Class II · device
Product
VITEK 2 REAGENT AST-ST02 TEST KIT 20 CARDS, CATALOG 420915
Reason for recall
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Distribution
US Nationwide distribution.
Key facts
- Status
- Ongoing
- Initiation date
- 2022-11-09
- Report date
- 2023-01-11
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Hazelwood, MO, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0848-2023