FDA Device recall Z-0680-2022
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
- FDA Device
- Class I
- terminated
- Published 2022-03-09
On 2022-03-09 the FDA classified a Class I recall of Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 by Celltrion Usa, citing 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 the….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0680-2022 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2021-12-02 |
| Published | 2022-03-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Celltrion Usa |
| Distribution | TX |
Product
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Reason
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.
Identifiers
| code_info | Lots COVGCCF0001, COVGCCF0002 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0680-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.