Celltrion DiaTrust COVID-19 Rapid Test Kits Recalled for Incorrect Expiration Dates
Celltrion USA Inc. is recalling 1.2 million DiaTrust COVID-19 rapid test kits due to incorrect expiration dates on packaging. The kits were distributed to 11 states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: FDA Class II labeling error with no reported illnesses or injuries. Incorrect expiration dating is a minor labeling error without evidence of actual harm, meeting the criteria for Moderate severity.
Plain-English summary
Celltrion USA Inc. is recalling the Celltrion DiaTrust COVID-19 Ag Rapid Test (Reference No. CT-P60 D-2 02) due to labeling with incorrect expiration dates. A total of 1,228,200 test kits are affected.
The recalled kits were distributed to the following states: California, Connecticut, Florida, Hawaii, Massachusetts, Montana, New Jersey, New York, Pennsylvania, Tennessee, and Texas. The affected lot numbers are COVGCCM0006, COVGCCM0007, COVGCCM0008, COVGCCM1002, COVGCCM1003, COVGCCM1004, COVGCCM1005, COVGCCM1006, and COVGCCM1007.
Incorrect expiration dating can compromise test reliability and result validity. Consumers who have purchased these test kits should stop using them and dispose of them according to local regulations or contact the manufacturer for guidance.
The recalled product
- Product
- Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
- Manufacturer
- CELLTRION USA INC
- Affected units
- 1,228,200
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 (9)
- Lot Numbers: COVGCCM0006
- COVGCCM0007
- COVGCCM0008
- COVGCCM1002
- COVGCCM1003
- COVGCCM1004
- COVGCCM1005
- COVGCCM1006
- COVGCCM1007
Distribution
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