Z-0558-2022Class II

Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with...

Name: Z-0558-2022 Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with...
Creator: Celltrion USA Inc
Published: 2021-12-01
License: https://open.fda.gov/license/

Celltrion USA Inc / initiated 2021-12-01 / Terminated / root cause: labeling and UDI

FDA source

CELLTRION USA INC began a recall of Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sterilized swabs per... on 2021-12-01. FDA classified it as Class II and gives the reason as "The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the U.S. but was illegally distributed in the U.S. The packaging and labeling of the European test kit is different from the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0558-2022
Classification: Class II
Status: Terminated
Initiated: 2021-12-01
Posted: 2022-02-03
Terminated: 2024-06-17
Recalling firm: Celltrion USA Inc
Product: Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sterilized swabs per box.
Product code: QKP Coronavirus Antigen Detection Test System.
Reason for recall: The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the U.S. but was illegally distributed in the U.S. The packaging and labeling of the European test kit is different from the US test kit and is NOT authorized for distribution in the US.
Root cause tag: labeling and UDI
FDA root cause: No Marketing Application
Action: Celltrion Healthcare informs Celltrion USA on 2021-11-11 that it had sent cease and desist letter to distributors who were illegally distributing non-EUA product in the U.S. Celltrion demanded return of all EU product from distributors' inventory and demanded removal of all EU DiaTrustTests from the U.S. In addition, the firm sent letters to all EU distributors warning against diversion and obtaining confirmation that distributors understand limitations on distribution only within the EU.
Quantity in commerce: 162,000 ea
Distribution: US Nationwide distribution in the state of CA.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0558-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0558-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-09	2022-02-03

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)