Lower riskMedical device recall · FDA · Published December 2, 2021
Celltr: RUO COVID-19 Test Kits Shipped to Customers - Safety Notice
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.
Take action
Contact the company
📍Recalling firmCELLTRION USA INC1 Evertrust Plz Ste 1207 · Jersey City, NJ 07302-3087
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/61479-celltr-ruo-covid-19-test-kits-shipped-to-customers-safety.
“Celltr: RUO COVID-19 Test Kits Shipped to Customers - Safety Notice.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61479-celltr-ruo-covid-19-test-kits-shipped-to-customers-safety. Based on FDA recall #Z-0680-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0680-2022%22&limit=1).
The FDA announced on Dec. 2, 2021, that Celltrion USA Inc. is recalling the Celltrion DiaTrust COVID-19 Ag Rapid Test because returned kits were erroneously shipped to customers for clinical diagnosis despite being labeled Research Use Only. The agency issued recall number Z-0680-2022 for the voluntary Class I action.
The recall addresses returned test kits that were erroneously shipped to customers who were unlikely to use them for Research Use Only purposes. The firm had provided a letter assuring distributors that these RUO tests could be used for clinical diagnosis, which is prohibited.
Context
GovInfoNow's records show Celltrion USA Inc. has four other recalls on record since Dec. 1, 2021. Other recent recalls of similar products include Vivoo Protein Test Recall (Nov. 22, 2025), Vivoo pH Test Recall (Nov. 22, 2025), and Vivoo Test Strips Recall (Nov. 22, 2025).
How to tell if you have this one
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.
Brand
Celltrion
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the reference number CT-P60 D-2 02 and lots COVGCCF0001 or COVGCCF0002 on the test kit packaging.
Where it went and when
Where it was distributed
Distributed in Texas.
Listed by the agency
Not listed
FDA distribution: “Distributed to TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Texas.
Recall timeline
FDA terminated this recall 2.5 years after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0680-2022 (December 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0680-2022 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.