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.
Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.
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.
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.
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.
Check the test's CLIA ID number. The product was distributed from December 2021 through February 2022. UPC: 8 806121 763044.
Look for the CLIA ID number on the test kit to determine if it was distributed without a valid ID.
The tests were distributed to customers who did not have a valid CLIA ID, which is required for authorized use.
Check the test's CLIA ID number. The product was distributed from December 2021 through February 2022 with UPC: 8 806121 763044.
No, but you should check if the test has a valid CLIA ID to ensure it was properly authorized.
We’ve drafted a message you can send Celltrion to request your refund or repair — edit it as you like.
Subject: Recall Z-0953-2022 — Celltrion Celltrion Hello, I own a Celltrion that is covered by recall Z-0953-2022 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.
