Celltrion USA recalls RUO COVID-19 test kits (CT-P60 D-2 02) shipped to customers by mistake. These kits are for research only and not approved for clinical use. No action needed as they are not intended for home use.
Returned test kits were erroneously shipped to customers. The kits are intended for Research Use Only (RUO). Additional RUO test kits were shipped to customers unlikely to use them for RUO purposes, and the firm provided a letter assuring distributors that RUO tests could be used for clinical diagnosis.
Celltrion USA recalled certain COVID-19 rapid test kits that were mistakenly shipped to customers. These kits are labeled for research use only and not approved for clinical diagnosis. Since they were never intended for home use, there is no risk to consumers.
The test kits were shipped to customers by mistake despite being labeled for research use only (RUO). The manufacturer provided a letter stating RUO tests could be used for clinical diagnosis, but this is not approved by regulatory authorities. Using these kits for clinical purposes could lead to incorrect results.
Customers who received the Celltrion DiaTrust COVID-19 Ag Rapid Test kits with reference number CT-P60 D-2 02 are likely affected. Those who used these kits for clinical diagnosis are at risk, but the kits were not intended for this purpose.
Check for the product name 'Celltrion DiaTrust COVID-19 Ag Rapid Test' with reference number CT-P60 D-2 02. The kits were shipped with lots COVGCCF0001 or COVGCCF0002.
Look for the reference number CT-P60 D-2 02 and lots COVGCCF0001 or COVGCCF0002 on the test kit packaging.
No, these kits are intended for research use only and not approved for clinical diagnosis. Using them for home testing could lead to incorrect results.
No action is needed as these kits were not intended for home use and were shipped by mistake. They are not approved for clinical diagnosis.
The manufacturer shipped these research-use-only kits to customers by mistake, despite the kits being labeled for research use only.
We’ve drafted a message you can send Celltrion to request your refund or repair — edit it as you like.
Subject: Recall Z-0680-2022 — Celltrion Celltrion Hello, I own a Celltrion that is covered by recall Z-0680-2022 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.
