FDA Device recall Z-0659-2022
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 the affected lot was placed under quarantine in September 2021 due to complaints of alleged false positives, but 243 kits were erroneously released to customers in December 2021.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0659-2022 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2021-12-28 |
| Published | 2022-03-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Celltrion Usa |
| Distribution | CA, FL, NJ, NY, PA, SC |
Product
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Reason
The affected lot was placed under quarantine in September 2021 due to complaints of alleged false positives, but 243 kits were erroneously released to customers in December 2021.
Identifiers
| code_info | Lot COVGCCM0008 |
|---|
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-0659-2022%22
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