CELLTRION USA INC FDA Record
- 3 Class I recalls
- No warning letters matched by name
CELLTRION USA INC has 5 FDA recalls (3 Class I), 0 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "CELLTRION USA INC" is on file.
- Latest recall
- Z-0953-2022 · Class I · Apr 1, 2022
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 5 (3 Class I) | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
CELLTRION USA INC: FDA recall records per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 2 | 1 |
| 2021 | 0 | 0 | 0 | 3 | 2 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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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 | Apr 1, 2022 |
| Z-0731-2022 | Class II | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 | Feb 25, 2022 |
| Z-0659-2022 | Class I | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 | Dec 28, 2021 |
| Z-0680-2022 | Class I | Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 | Dec 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… | Dec 1, 2021 |
CELLTRION USA INC and the FDA: common questions
Has CELLTRION USA INC received an FDA warning letter?
No FDA warning letter addressed to the name "CELLTRION USA INC" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has CELLTRION USA INC received an FDA Form 483?
FDA has not published a Form 483 for "CELLTRION USA INC" in its reading room. FDA publishes some Form 483s, not all of them.
Has CELLTRION USA INC had an FDA recall?
Yes. CELLTRION USA INC has 5 FDA recalls on record, 3 of them Class I, the most serious class. The most recent started Apr 1, 2022.
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