Agency classClass IOur severity:Severe FDA (Devices)·Z-0680-2022·Announced 2022-03-09

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.

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 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:

Same manufacturer · CELLTRION USA INC

See all →

Severe
Celltrion DiaTrust COVID-19 Rapid Test distributed to unqualified facilities
FDA (Devices) · 2022-05-04
Moderate
Celltrion DiaTrust COVID-19 Rapid Test Kits Recalled for Incorrect Expiration Dates
FDA (Devices) · 2022-03-16
Severe
COVID-19 Rapid Test Kits Recalled for Risk of False Positive Results
FDA (Devices) · 2022-03-09
Moderate
Celltrion DiaTrust COVID-19 Rapid Test Recalled—Unapproved European Version Distributed
FDA (Devices) · 2022-02-09

Same hazard · mis labeling