Device product
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Z-0953-2022
Product summary
- Event
- Event 89965
- Status
- Terminated
- Classification
- Class I
- Quantity
- 12,632 kits
- Official record key
device-enforcement:Z-0953-2022
Official wording
Reason: Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.
Code information: All lots distributed to end users without valid CLIA ID UPC: 8 806121 763044 Distributed from December 2021 through February 2022.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.