Z-0680-2022 Class I Terminated
FDA device recall Z-0680-2022 was initiated by CELLTRION USA INC on Dec 2, 2021 and is designated Class I. 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… The recall status is terminated (terminated Jun 10, 2024). Affected quantity: 8080 kits originally distributed; 726 kits redistributed.
Recall details
- Product Type
- Devices
- Report Date
- Mar 9, 2022
- Initiation Date
- Dec 2, 2021
- Termination Date
- Jun 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0680-2022
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026