CELLTRION USA INC recalls
Every recall we track for CELLTRION USA INC — 5 in all, from 2021–2022 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from CELLTRION USA INC peaked in 2021 (3); 5 since 2017.
All FDA recall records for CELLTRION USA INC since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 2 | 1 | 3 |
| 2022 | 0 | 0 | 2 | 0 | 2 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled CELLTRION USA INC product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All CELLTRION USA INC recalls
5 shown- Lower riskMedical device
CELLTRION USA INC recalls Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Celltrion recalls DiaTrust COVID-19 Ag Rapid Test kits distributed without valid CLIA ID. Consumers may need to check their test's CLIA ID to determine if recalled.
CelltrionApr 1, 2022 - Lower riskMedical device
CELLTRION USA INC recalls Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Celltrion recalls specific lots of DiaTrust COVID-19 Ag Rapid Test kits due to incorrect expiration dates. Consumers should check their lot numbers to determine if affected.
CelltrionFeb 25, 2022 - Lower riskMedical device
CELLTRION USA INC recalls Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Celltrion recalls 243 units of DiaTrust COVID-19 Ag Rapid Test (Lot COVGCCM0008) due to false positives reported in December 2021. Affected customers should contact for replacement.
CelltrionDec 28, 2021 - Lower riskMedical device
CELLTRION USA INC recalls Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Celltrion USA recalls RUO COVID-19 test kits (CT-P60 D-2 02) shipped to customers by mistake. These kits are for research only and not approved for clinical use. No action needed as they are not intended for home use.
CelltrionDec 2, 2021 - UnratedMedical device
CELLTRION USA INC recalls Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 disposable test tubes with extraction buffer,
Celltrion USA recalls DiaTrust COVID-19 Ag Rapid Test (REF CT-P60 D-2 01) as it was illegally distributed in the U.S. without U.S. approval. The European version has different packaging and labeling not authorized for U.S. distribution.
CelltrionDec 1, 2021
CELLTRION USA INC recall questions
How many recalls has CELLTRION USA INC had?
5 recalls from CELLTRION USA INC are on record with U.S. safety agencies, from 2021–2022.
What is the most recent CELLTRION USA INC recall?
CELLTRION USA INC recalls Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02, dated Apr 1, 2022. Every CELLTRION USA INC recall is listed on this page, newest first.
What should I do if I have a recalled CELLTRION USA INC product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new CELLTRION USA INC recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.