UnratedMedical device recall · FDA · Published December 1, 2021
Celltr: DiaTrust COVID-19 Ag Rapid Test Not Approved for U.S. Use
Celltrion USA recalls DiaTrust COVID-19 Ag Rapid Test (REF CT-P60 D-2 01) as it was illegally distributed in the U.S. without U.S. approval. The European version has different packaging and labeling not authorized for U.S. distribution.
The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the U.S. but was illegally distributed in the U.S. The packaging and labeling of the European test kit is different from the US test kit and is NOT authorized for distribution in the US.
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Contact the company
📍Recalling firmCELLTRION USA INC1 Evertrust Plz Ste 1207 · Jersey City, NJ 07302-3087
✎ GovInfoNow plain-language explainer
Celltrion USA is recalling its DiaTrust COVID-19 Ag Rapid Test (REF CT-P60 D-2 01) because it was illegally distributed in the U.S. without U.S. approval. This product is not approved for U.S. use and has different packaging and labeling than the authorized U.S. version. Read more at govinfonow.com/recall/61484-celltr-diatrust-covid-19-ag-rapid-test-not-approved-for.
“Celltr: DiaTrust COVID-19 Ag Rapid Test Not Approved for U.S. Use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61484-celltr-diatrust-covid-19-ag-rapid-test-not-approved-for. Based on FDA recall #Z-0558-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0558-2022%22&limit=1).
The FDA announced on Dec. 1, 2021, that Celltrion USA Inc. recalled the Celltrion DiaTrust COVID-19 Ag Rapid Test because the European version was illegally distributed in the U.S. The product contained different packaging and labeling not authorized for U.S. distribution.
Distribution: US Nationwide distribution in the state of CA
The hazard
The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the U.S. but was illegally distributed in the U.S., according to the FDA. The packaging and labeling of the European test kit is different from the US test kit and is NOT authorized for distribution in the US.
Context
GovInfoNow's records show Celltrion USA Inc. has 4 other recalls on record since Dec. 2, 2021. Other recent recalls of similar products include Syphilis Test Recall (Nov. 3, 2025), GET TESTED Diabetes Test Kits (Nov. 3, 2025) and GET TESTED D-Dimer Test Recall (Nov. 3, 2025).
How to tell if you have this one
Look for the product name 'Celltrion DiaTrust COVID-19 Ag Rapid Test' with the reference number CT-P60 D-2 01. The product was sold in the U.S. without U.S. approval.
Brand
Celltrion
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the product reference number is CT-P60 D-2 01 and that it was sold in the U.S. without U.S. approval.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of CA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.5 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-0558-2022 (December 1, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0558-2022 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.