Z-0680-2022Class I

Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02

Name: Z-0680-2022 Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Creator: Celltrion USA Inc
Published: 2021-12-02
License: https://open.fda.gov/license/

Celltrion USA Inc / initiated 2021-12-02 / Terminated / root cause: manufacturing process

FDA source

CELLTRION USA INC began a recall of Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 on 2021-12-02. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0680-2022
Classification: Class I
Status: Terminated
Initiated: 2021-12-02
Posted: 2022-03-02
Terminated: 2024-06-10
Recalling firm: Celltrion USA Inc
Product: Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Product code: QKP Coronavirus Antigen Detection Test System.
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On December 2, 2021, the firm notified the affected distributor that the two lots are Research Use Only and should not be used. The distributor then notified the customer. Customer reported all product had been used.
Quantity in commerce: 8080 kits originally distributed; 726 kits redistributed
Distribution: Distributed to TX.
Product codes and lots: Lots COVGCCF0001, COVGCCF0002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0680-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0680-2022	Class I	Terminated	Voluntary: Firm initiated	2022-03-09	2022-03-02

Product code QKP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)