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.
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.
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.
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.
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.
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.
Look for the lot number COVGCCM0008 on the test kit packaging to confirm if it's affected.
The recall is because 243 kits were mistakenly released after being quarantined in September 2021 due to false positive complaints.
243 kits with lot number COVGCCM0008 were released in December 2021.
No action is needed if the lot number is not COVGCCM0008. Affected kits should be contacted for replacement.
We’ve drafted a message you can send Celltrion to request your refund or repair — edit it as you like.
Subject: Recall Z-0659-2022 — Celltrion Celltrion Hello, I own a Celltrion that is covered by recall Z-0659-2022 from Celltrion. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
