COVID-19 Rapid Test Kits Recalled for Risk of False Positive Results
Celltrion DiaTrust COVID-19 Ag Rapid Test kits from lot COVGCCM0008 are being recalled due to reports of false positive results. The affected 243 kits were distributed to six states before the recall.
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 is an FDA Class I recall, which automatically qualifies for a minimum severity score of 4. The defect—false positive COVID-19 test results—creates potential for serious health consequences through unnecessary medical interventions or isolation, though no injuries or illnesses have been reported.
Plain-English summary
Celltrion USA Inc. is recalling 243 kits (6,075 individual tests) of the Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02, from lot number COVGCCM0008. The affected lot was placed under quarantine in September 2021 following complaints of false positive results.
Despite the quarantine, 243 kits from this lot were erroneously released to customers in December 2021. This represents a distribution error in which quarantined product reached end users.
The kits were distributed to customers in California, Florida, New Jersey, New York, Pennsylvania, and South Carolina.
If you have tests from lot COVGCCM0008, you should stop using them and contact Celltrion USA Inc. or your healthcare provider. False positive COVID-19 test results could lead to unnecessary isolation or medical treatment. Anyone who received a positive result from these kits during the distribution period should consult with a healthcare provider for confirmatory testing.
The recalled product
- Product
- Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
- Manufacturer
- CELLTRION USA INC
- Hazard
- false-positive
- diagnostic-error
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)
- Lot COVGCCM0008
Distribution
Distributed in 6 states:
- CA
- FL
- NJ
- NY
- PA
- SC
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