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Celltrion USA Recalls SARS-CoV-2 Antigen Tests Due to High False-Positive Results

NEW YORK – The US Food and Drug Administration on Tuesday said that Celltrion USA, a subsidiary of South Korea-based Celltrion, is recalling specific lots of its DiaTrust COVID-19 Ag Rapid Tests due to a high number of false-positive test results and a mislabeled shelf life.

The antigen tests’ labeling includes a shelf life of 18 months, while the FDA’s Emergency Use Authorization specifies that they may be used for 12 months.

The Celltrion DiaTrust COVID-19 Ag Rapid Test detects SARS-CoV-2 from a nasopharyngeal swab collected by healthcare providers at the point of care.

The FDA said the recall is Class I, the most serious type. Although there have been no reports of injuries, use of the affected product could cause serious adverse health consequences and death, the agency said. 

On Feb. 28, Celltrion USA sent letters to some affected distributors and customers with instructions to discontinue use of the antigen tests, return all unused products, and complete and return an acknowledgement and receipt form, the FDA said. Celltrion has recalled 45,500 tests in the US.

Celltrion received FDA Emergency Use Authorization for the DiaTrust COVID-19 Ag Rapid Test last April.

Earlier this month, the agency had warned against use of the test if it comes in green and white packaging.

The firm received FDA EUA for an over-the-counter, at-home SARS-CoV-2 test in October.