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-0680-2022
- Recalling firm
- CELLTRION USA INC
- Product
- Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
- Status
- Terminated
- Initiated
- 2021-12-02
- Posted
- 2022-03-02
- Terminated
- 2024-06-10
- Reason
- Returned test kits were erroneously shipped to customers. The kits are intended for Research Use Only (RUO). Additional RUO test kits were shipped to customers unlikely to use them for RUO purposes, and the firm provided a letter assuring distributors that RUO tests could be used for clinical diagnosis.
- Root cause
- Employee error
- Action
- On December 2, 2021, the firm notified the affected distributor that the two lots are Research Use Only and should not be used. The distributor then notified the customer. Customer reported all product had been used.
- Quantity
- 8080 kits originally distributed; 726 kits redistributed
- Distribution
- Distributed to TX.
- Lot, serial or model codes
- Lots COVGCCF0001, COVGCCF0002
- 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