FDA Medical Device Recalls (openFDA)
CELLTRION USA INC: Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
- Recall number
- Z-0731-2022
- Recalling firm
- CELLTRION USA INC
- Product
- Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
- Status
- Open, Classified
- Initiated
- 2022-02-25
- Posted
- 2022-03-08
- Terminated
- not on file
- Reason
- Kits were labeled with incorrect expiration dates.
- 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 celltrionusa.CS@celltrion.com 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 celltrionusa.CS@celltrion.com.
- Quantity
- 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.
- Lot, serial or model codes
- Lot Numbers: COVGCCM0006, COVGCCM0007, COVGCCM0008, COVGCCM1002, COVGCCM1003, COVGCCM1004, COVGCCM1005, COVGCCM1006, COVGCCM1007
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QKP
- Firm FEI
- 3015423092
- Firm city
- Jersey City
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28