Biotech companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of CelltrionLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Celltrion USA with 5 device recalls. The most recent is a device recall dated Apr 1, 2022: Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Apr 1, 2022 | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02Class I · Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID. | Device recalls |
| Feb 25, 2022 | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02Class II · Kits were labeled with incorrect expiration dates. | Device recalls |
| Dec 28, 2021 | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02Class I · The affected lot was placed under quarantine in September 2021 due to complaints of alleged false positives, but 243 kit | Device recalls |
| Dec 2, 2021 | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02Class I · Returned test kits were erroneously shipped to customers. The kits are intended for Research Use Only (RUO). Additional | Device recalls |
| Dec 1, 2021 | 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 sClass II · The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the U.S. but was illegally | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
