Z-0953-2022Class I

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

Name: Z-0953-2022 Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Creator: Celltrion USA Inc
Published: 2022-04-01
License: https://open.fda.gov/license/

Celltrion USA Inc / initiated 2022-04-01 / Terminated

FDA source

CELLTRION USA INC began a recall of Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 on 2022-04-01. FDA classified it as Class I and gives the reason as "Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0953-2022
Classification: Class I
Status: Terminated
Initiated: 2022-04-01
Posted: 2022-04-27
Terminated: 2024-06-11
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: Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.
FDA root cause: Other
Action: On April 1, 2022, the firm notified distributors of the issue via letter, following up with meetings with each distributor on April 5, 2022 and emails on April 6, 2022. The firm instructed distributors to communicate the recall to their affected customers, down to the user level. Customers who do not have CLIA IDs must return the product to their distributors.
Quantity in commerce: 12,632 kits
Distribution: US Nationwide distribution.
Product codes and lots: All lots distributed to end users without valid CLIA ID UPC: 8 806121 763044 Distributed from December 2021 through February 2022.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0953-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0953-2022	Class I	Terminated	Voluntary: Firm initiated	2022-05-04	2022-04-27

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)