Z-0659-2022Class I

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

Name: Z-0659-2022 Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Creator: Celltrion USA Inc
Published: 2021-12-28
License: https://open.fda.gov/license/

Celltrion USA Inc / initiated 2021-12-28 / 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 2021-12-28. FDA classified it as Class I and gives the reason as "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". 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-0659-2022
Classification: Class I
Status: Terminated
Initiated: 2021-12-28
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: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm initially placed a hold on product due to complaints of false positive and false negative results in September 2021. After product was erroneously distributed from this lot in December 2021, the firm notified affected customers that the lot should not have been distributed and should not be used. This email went out on or around December 28, 2021. Customers were instructed to NOT use the affected lot.
Quantity in commerce: 243 kits (6,075 tests)
Distribution: US distribution to CA, FL, NJ, NY, PA, SC.
Product codes and lots: Lot COVGCCM0008

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0659-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0659-2022	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)