--- title: "CELLTRION USA INC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search CELLTRION USA INC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/celltrion-usa-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # CELLTRION USA INC recall records **1** reported ongoing 5 records in this archive. Latest source date Apr 1, 2022. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Apr 1, 2022 FDA device enforcement ### [Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02](https://isitonrecall.com/recall/fda-device-z-0953-2022-celltrion-diatrust-covid-19-ag-rapid-test-reference-no-ct-p60-d-2-02/) Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID. Class I Reported terminated Distribution: US Nationwide distribution. [Official source for Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0953-2022%22) Feb 25, 2022 FDA device enforcement ### [Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02](https://isitonrecall.com/recall/fda-device-z-0731-2022-celltrion-diatrust-covid-19-ag-rapid-test-reference-no-ct-p60-d-2-02/) Kits were labeled with incorrect expiration dates. Class II Reported ongoing Distribution: The products were distributed to the following US states: CA, CT, FL, HI, MA, MT, NJ, NY, PA, TN, and TX. [Official source for Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0731-2022%22) Dec 28, 2021 FDA device enforcement ### [Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02](https://isitonrecall.com/recall/fda-device-z-0659-2022-celltrion-diatrust-covid-19-ag-rapid-test-reference-no-ct-p60-d-2-02/) 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. Class I Reported terminated Distribution: US distribution to CA, FL, NJ, NY, PA, SC. [Official source for Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0659-2022%22) Dec 2, 2021 FDA device enforcement ### [Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02](https://isitonrecall.com/recall/fda-device-z-0680-2022-celltrion-diatrust-covid-19-ag-rapid-test-reference-no-ct-p60-d-2-02/) 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 ... Class I Reported terminated Distribution: Distributed to TX. [Official source for Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0680-2022%22) Dec 1, 2021 FDA device enforcement ### [Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer, 25 filter caps, 25 sterilized swabs per box.](https://isitonrecall.com/recall/fda-device-z-0558-2022-celltrion-diatrust-covid-19-ag-rapid-test-ref-ct-p60-d-2-01-contains-25-disposable-test-tubes-with-e/) 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 d... Class II Reported terminated Distribution: US Nationwide distribution in the state of CA. [Official source for Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes w...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0558-2022%22) ## Reasons in these listed records - Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID. - Kits were labeled with incorrect expiration dates. - 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. - 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 u... These examples come from this result page and are not a ranking of every recall reason. ## Checking CELLTRION USA INC ### Is there a recall on celltrion usa inc right now? This archive contains 5 records, including 1 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search CELLTRION USA INC](https://isitonrecall.com/check/?q=CELLTRION%20USA%20INC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)