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.
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.
The European version of this test kit was not approved for marketing in the U.S. and has different packaging and labeling than the authorized U.S. version. This means it may not function properly or could pose risks if used without proper U.S. approval.
Anyone who purchased this specific test kit in the U.S. is affected. The product was illegally distributed, so it's not intended for U.S. use.
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.
Verify the product reference number is CT-P60 D-2 01 and that it was sold in the U.S. without U.S. approval.
No, this European version was not approved for U.S. use and has different packaging and labeling than the authorized U.S. version.
It was illegally distributed in the U.S. without U.S. approval, and the European version has different packaging and labeling not authorized for U.S. distribution.
The official recall notice does not specify a remedy, so check with Celltrion USA for further instructions.
We’ve drafted a message you can send Celltrion to request your refund or repair — edit it as you like.
Subject: Recall Z-0558-2022 — Celltrion Celltrion Hello, I own a Celltrion that is covered by recall Z-0558-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
