Lower riskMedical device recall · FDA · Published February 25, 2022
Celltrion DiaTrust COVID- 19 Ag Rapid Test Recall: Incorrect Expiration Dates
Celltrion recalls specific lots of DiaTrust COVID-19 Ag Rapid Test kits due to incorrect expiration dates. Consumers should check their lot numbers to determine if affected.
“Celltrion DiaTrust COVID- 19 Ag Rapid Test Recall: Incorrect Expiration Dates.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61026-celltrion-diatrust-covid-19-ag-rapid-test-recall-incorrect-expiration. Based on FDA recall #Z-0731-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0731-2022%22&limit=1).
The FDA announced on Feb. 25, 2022, that Celltrion USA Inc. is recalling Celltrion DiaTrust COVID-19 Ag Rapid Test kits due to incorrect expiration dates on the labels. Owners should stop using the affected lots immediately.
Distribution states: CA, CT, FL, HI, MA, MT, NJ, NY, PA, TN, TX
The hazard
The kits were labeled with incorrect expiration dates, according to the FDA.
Context
GovInfoNow's records show Celltrion USA Inc. has four other recalls on record since Dec. 1, 2021. Other recent recalls of similar products include Exploro Fertility Test Recall (Nov. 22, 2025), Urinary Clean Catch Kit Recalled Due to Incorrect Expiration Date (July 9, 2026), and Medtronic Pocket Adaptor Kits with Incorrect Use-By Dates Recalled (May 13, 2026).
How to tell if you have this one
Check the lot number on the test kit packaging. Affected lots are COVGCCM0006, COVGCCM0007, COVGCCM0008, COVGCCM1002, COVGCCM1003, COVGCCM1004, COVGCCM1005, COVGCCM1006, and COVGCCM1007.
Brand
Celltrion
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Lot Number
Look for the lot number on the test kit packaging to see if it matches the affected lots listed: COVGCCM0006 to COVGCCM1007.
Where it went and when
Where it was distributed
Distributed in 11 states.
Listed by the agency
Not listed
FDA distribution: “The products were distributed to the following US states: CA, CT, FL, HI, MA, MT, NJ, NY, PA, TN, and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Connecticut, Florida, Hawaii, Massachusetts, Montana, New Jersey, New York, Pennsylvania, Tennessee, Texas.
Recall timeline
FDA published this recall 19 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0731-2022 (February 25, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0731-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.