Z-0680-2022 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 9, 2022
- Initiation Date
- December 2, 2021
- Termination Date
- June 10, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8080 kits originally distributed; 726 kits redistributed
Product Description
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Reason for Recall
Returned test kits were erroneously shipped to customers. The kits are intended for Research Use Only (RUO). Additional RUO test kits were shipped to customers unlikely to use them for RUO purposes, and the firm provided a letter assuring distributors that RUO tests could be used for clinical diagnosis.
Distribution Pattern
Distributed to TX.
Code Information
Lots COVGCCF0001, COVGCCF0002