FDA recall Z-0789-2023
Biomerieux Inc · Class II · device
Product
VITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS, CATALOG 21343
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-0789-2023