CELLTRION USA INC
CELLTRION USA INC appears in FDA public data with 5 recalls — including 3 Class I (most serious) —, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0953-2022, Class I) was initiated on April 1, 2022.
Summary
- Total Recalls
- 5 (3 Class I)
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0953-2022 | Class I | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 | April 1, 2022 |
| Z-0731-2022 | Class II | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 | February 25, 2022 |
| Z-0659-2022 | Class I | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 | December 28, 2021 |
| Z-0680-2022 | Class I | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 | December 2, 2021 |
| Z-0558-2022 | Class II | Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with | December 1, 2021 |