Celltrion DiaTrust COVID-19 Ag Rapid Test Recall: CLIA ID Required
Celltrion recalls DiaTrust COVID-19 Ag Rapid Test kits distributed without valid CLIA ID. Consumers may need to check their test's CLIA ID to determine if recalled.
Lower-risk recall
Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.
Contact the company
What happened, in plain English
Celltrion is recalling its DiaTrust COVID-19 Ag Rapid Test kits that were distributed to customers without a valid CLIA ID. This recall is because the tests were not properly authorized for use, which could lead to inaccurate results. Read more at govinfonow.com/recall/60845-celltrion-diatrust-covid-19-ag-rapid-test-recall-clia-id.
Source Summary by GovInfoNow · govinfonow.com/recall/60845-celltrion-diatrust-covid-19-ag-rapid-test-recall-clia-id · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0953-2022
Cite this page
“Celltrion DiaTrust COVID-19 Ag Rapid Test Recall: CLIA ID Required.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60845-celltrion-diatrust-covid-19-ag-rapid-test-recall-clia-id. Based on FDA recall #Z-0953-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0953-2022%22&limit=1).
Why it’s dangerous
The tests were distributed without a valid CLIA (Clinical Laboratory Improvement Amendments) ID, which is required for authorized use. This means the tests might not work correctly, leading to inaccurate results.
Who’s affected
Anyone who purchased the Celltrion DiaTrust COVID-19 Ag Rapid Test with a CLIA ID number from December 2021 through February 2022. People using these tests without a valid CLIA ID are most at risk.
How to tell if you have this one
Check the test's CLIA ID number. The product was distributed from December 2021 through February 2022. UPC: 8 806121 763044.
- Brand
Celltrion- Product
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02- Category
Medical device
What to do — step by step
Check CLIA ID
Look for the CLIA ID number on the test kit to determine if it was distributed without a valid ID.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0953-2022 (April 1, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0953-2022 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.