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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
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
Related recalls
Same manufacturer · CELLTRION USA INC
See all →- SevereCelltrion DiaTrust COVID-19 Rapid Test distributed to unqualified facilities
FDA (Devices) · 2022-05-04
- ModerateCelltrion DiaTrust COVID-19 Rapid Test Kits Recalled for Incorrect Expiration Dates
FDA (Devices) · 2022-03-16
- SevereCelltrion DiaTrust COVID-19 Rapid Test Kits Recalled for Unauthorized Clinical Use
FDA (Devices) · 2022-03-09
- ModerateCelltrion DiaTrust COVID-19 Rapid Test Recalled—Unapproved European Version Distributed
FDA (Devices) · 2022-02-09
Same hazard · false positive
See all →- ModerateBioFire FilmArray Pneumonia Panel Plus Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateBioFire Joint Infection Panel Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- HighAlere San Diego Recalls hCG Urine Pregnancy Tests for False Positives
FDA (Devices) · 2026-10-07
- HighHealthmark ProChek-II Medical Tests Recalled for Expired Ingredient
FDA (Devices) · 2026-09-02
- HighpTau 217 plasma calibrators recalled over falsely elevated ratio results
FDA (Devices) · 2026-02-11
Similar recalls
- ModerateCelltrion DiaTrust COVID-19 Rapid Test Kits Recalled for Incorrect Expiration Dates
FDA (Devices) · 2022-03-16
- SevereCelltrion DiaTrust COVID-19 Rapid Test Kits Recalled for Unauthorized Clinical Use
FDA (Devices) · 2022-03-09
- SevereCelltrion DiaTrust COVID-19 Rapid Test distributed to unqualified facilities
FDA (Devices) · 2022-05-04
- ModerateCelltrion DiaTrust COVID-19 Rapid Test Recalled—Unapproved European Version Distributed
FDA (Devices) · 2022-02-09
- SevereFDA Recalls Unauthorized E25Bio COVID-19 Diagnostic Test Kit
FDA (Devices) · 2022-02-16
- SevereCOVID-19 Rapid Antigen Test Kit Distributed Without FDA Approval
FDA (Devices) · 2022-02-09