Celltrion DiaTrust COVID-19 Rapid Test Kits Recalled for Unauthorized Clinical Use
Celltrion USA recalled COVID-19 rapid test kits (DiaTrust) in a Class I action. The kits are labeled for research use only, but the firm assured distributors they could be used for clinical diagnosis, which is not authorized.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall receives FDA Class I classification, which mandates a severity score of at least 4. The hazard is the misrepresentation of Research Use Only tests as suitable for clinical diagnosis; while no illnesses or injuries have been reported, the unauthorized use of non-clinical tests in clinical settings constitutes serious regulatory non-compliance.
Plain-English summary
Celltrion USA has recalled COVID-19 rapid test kits (DiaTrust, Reference No. CT-P60 D-2 02, Lots COVGCCF0001 and COVGCCF0002) in a Class I action. The recall involves 8,080 kits originally distributed to Texas, with an additional 726 kits redistributed.
The kits are labeled for Research Use Only (RUO) and are not FDA-approved for clinical diagnosis. The recall was triggered by two issues: returned test kits were erroneously shipped back to customers, and additional RUO test kits were shipped to customers unlikely to use them for their intended research purpose. The firm further provided assurance to distributors that RUO tests could be used for clinical diagnosis, which is not authorized.
If you have these test kits, do not use them for clinical diagnosis purposes. For FDA-approved COVID-19 testing, use only tests cleared by the FDA for clinical use.
The recalled product
- Product
- Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
- Manufacturer
- CELLTRION USA INC
- Category
- Medical Device
- Hazard
- mis-labeling
- unauthorized-use
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 (2)
- Lots COVGCCF0001
- COVGCCF0002
Distribution
Distributed in 1 state:
- TX
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