Celltrion DiaTrust COVID-19 Ag Rapid Test Recall: False Positives Risk
Celltrion recalls 243 units of DiaTrust COVID-19 Ag Rapid Test (Lot COVGCCM0008) due to false positives reported in December 2021. Affected customers should contact for replacement.
Lower-risk recall
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.
Contact the company
What happened, in plain English
Celltrion is recalling 243 units of its DiaTrust COVID-19 Ag Rapid Test (Lot COVGCCM0008) because they were mistakenly released after being quarantined in September 2021 due to false positive complaints. This means some people might get incorrect positive results, which could lead to unnecessary anxiety or actions. Read more at govinfonow.com/recall/61333-celltrion-diatrust-covid-19-ag-rapid-test-recall-false-positives.
Source Summary by GovInfoNow · govinfonow.com/recall/61333-celltrion-diatrust-covid-19-ag-rapid-test-recall-false-positives · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0659-2022
Cite this page
“Celltrion DiaTrust COVID-19 Ag Rapid Test Recall: False Positives Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61333-celltrion-diatrust-covid-19-ag-rapid-test-recall-false-positives. Based on FDA recall #Z-0659-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0659-2022%22&limit=1).
Why it’s dangerous
The test kits were placed under quarantine in September 2021 after false positive complaints were reported. However, 243 kits were mistakenly released to customers in December 2021, meaning some users might get incorrect positive results.
Who’s affected
Anyone who purchased the Celltrion DiaTrust COVID-19 Ag Rapid Test (Lot COVGCCM0008) between December 2021 and the recall announcement. People who use the test for home COVID-19 screening are most at risk of false positives.
How to tell if you have this one
Check for the product name 'Celltrion DiaTrust COVID-19 Ag Rapid Test' and the lot number COVGCCM0008. The recall covers 243 kits released in December 2021.
- Brand
Celltrion- Category
Medical device
What to do — step by step
Check Product Details
Look for the lot number COVGCCM0008 on the test kit packaging to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed in 6 states.
FDA distribution: “US distribution to CA, FL, NJ, NY, PA, SC.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Florida, New Jersey, New York, Pennsylvania, South Carolina.
Recall timeline
FDA terminated this recall 2.5 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-0659-2022 (December 28, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0659-2022 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.