Celltrion DiaTrust COVID-19 Rapid Test Recalled—Unapproved European Version Distributed
Celltrion USA Inc. is recalling 162,000 units of the European version of its DiaTrust COVID-19 Ag Rapid Test, which was not approved for U.S. distribution. The test packaging and labeling differ from the FDA-approved U.S. version.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving distribution of an unapproved European version of a diagnostic device. No illnesses or injuries have been reported. The primary issues are regulatory non-compliance and unauthorized distribution with labeling differences, warranting a Moderate severity score without reported harm.
Plain-English summary
Celltrion USA Inc. is recalling 162,000 units of the DiaTrust COVID-19 Ag Rapid Test (REF CT-P60 D-2 01), affecting all lots produced. The recalled product is the European version of this COVID-19 test kit, which comes in boxes containing 25 disposable test tubes with extraction buffer, 25 filter caps, and 25 sterilized swabs per box, distributed nationwide.
The European version of the test was not approved for marketing in the United States but was illegally distributed here. The packaging and labeling of the European test kit are different from the FDA-approved U.S. version and are not authorized for distribution in the United States.
Anyone who may have purchased this test kit should verify they have the U.S.-approved version before use. Do not use the European version. Consumers with questions or concerns should contact Celltrion USA Inc. for further guidance.
The recalled product
- Product
- 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.
- Manufacturer
- CELLTRION USA INC
- Category
- Medical Device — Diagnostic Test
- Hazard
- unapproved-device
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots
Distribution
Distributed nationwide across the United States.
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