CELLTRION USA INC
CELLTRION USA INC has 5 FDA enforcement events on this register (5 product records) between 2021 and 2022: 5 device; the busiest year was 2021 with 3.
60% of its events are Class I; the most common class is Class I (3). 1 event is listed as ongoing; the recalling firm's address is in NJ.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 1 Apr 2022 | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 | Device | Class I | 1 | Terminated |
| 25 Feb 2022 | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 | Device | Class II | 1 | Ongoing |
| 28 Dec 2021 | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 | Device | Class I | 1 | Terminated |
| 2 Dec 2021 | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 | Device | Class I | 1 | Terminated |
| 1 Dec 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 sterilized swabs per box. | Device | Class II | 1 | Terminated |
By type and class
Class I: 60% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has CELLTRION USA INC had?
5 enforcement events (5 product records) on this register, 2021–2022: 5 device.
Are any CELLTRION USA INC recalls ongoing?
1 event is listed as ongoing in the current openFDA export.
What class are CELLTRION USA INC recalls?
3 Class I, 2 Class II. 60% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.