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-0659-2022
- Recalling firm
- CELLTRION USA INC
- Product
- Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
- Status
- Terminated
- Initiated
- 2021-12-28
- Posted
- 2022-03-02
- Terminated
- 2024-06-10
- Reason
- 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
- 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
- 243 kits (6,075 tests)
- Distribution
- US distribution to CA, FL, NJ, NY, PA, SC.
- Lot, serial or model codes
- Lot COVGCCM0008
- 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