Z-0731-2022Class II

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

Name: Z-0731-2022 Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Creator: Celltrion USA Inc
Published: 2022-02-25
License: https://open.fda.gov/license/

Celltrion USA Inc / initiated 2022-02-25 / Open, Classified / root cause: labeling and UDI

FDA source

CELLTRION USA INC began a recall of Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 on 2022-02-25. FDA classified it as Class II and gives the reason as "Kits were labeled with incorrect expiration dates". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0731-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-02-25
Posted: 2022-03-08
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: Kits were labeled with incorrect expiration dates.
Root cause tag: labeling and UDI
FDA root cause: Incorrect or no expiration date
Action: An URGENT: MEDICAL DEVICE RECALL notification letter dated 2/25/22 was sent to customers. Immediate Actions to be taken by You: 1. Examine your inventory for affected product. Please identify the LOT number printed on the outer box to determine whether the products you received are from lots COVGCCM0006, COVGCCM0007, COVGCCM0008, COVGCCM1002, COVGCCM1003, COVGCCM1004, COVGCCM1005, COVGCCM1006 or COVGCCM1007. 2. If you identify kits from the lots above in your inventory, quarantine the products and do not use them. 3. If you identified kits with Lot Number COVGCCM0006, COVGCCM0007, COVGCCM0008, COVGCCM1002, COVGCCM1003, COVGCCM1004, COVGCCM1005, COVGCCM1006 or COVGCCM1007, please contact [email protected] and Celltrion USA, Inc. will provide the shipping label for return to the address below. Celltrion USA, Inc. One Evertrust Plaza Suite 1207, Jersey City, New Jersey, 07302, USA 4. Please complete the enclosed Acknowledgement and Receipt Form with the information requested and return the form in accordance with the instructions on the form. Please complete this form even if you do not have the product on hand. For additional questions, please contact Celltrion USA by calling +1 (201) 320-2023 Monday through Friday, 9:00 AM to 6:00 PM or email to [email protected].
Quantity in commerce: 1,228,200 tests
Distribution: The products were distributed to the following US states: CA, CT, FL, HI, MA, MT, NJ, NY, PA, TN, and TX.
Product codes and lots: Lot Numbers: COVGCCM0006, COVGCCM0007, COVGCCM0008, COVGCCM1002, COVGCCM1003, COVGCCM1004, COVGCCM1005, COVGCCM1006, COVGCCM1007

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0731-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0731-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-03-16	2022-03-08

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)