FDA recall Z-0872-2023
Biomerieux Inc · Class II · device
Product
PPM LOMBARD PRODUCTS CT&TI-TSA + L & P80 10PLT, CATALOG C6045-TI
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-0872-2023