FDA recall Z-0953-2022
CELLTRION USA INC · Class I · device
Product
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Reason for recall
Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.
Distribution
US Nationwide distribution.
Key facts
- Status
- Terminated
- Initiation date
- 2022-04-01
- Report date
- 2022-05-04
- Termination date
- 2024-06-11
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Jersey City, NJ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0953-2022