FDA Device recall Z-0953-2022
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
- FDA Device
- Class I
- terminated
- Published 2022-05-04
On 2022-05-04 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 point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0953-2022 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2022-04-01 |
| Published | 2022-05-04 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Celltrion Usa |
| Distribution | US |
Product
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Reason
Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.
Identifiers
| upc | 8806121763044 |
|---|---|
| code_info | All lots distributed to end users without valid CLIA ID UPC: 8 806121 763044 Distributed from December 2021 through February 2022. |
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-0953-2022%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.