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COVID-19 Rapid Test Recalled for “High Number” of False Positives

The U.S. FDA announced Wednesday (March 16) that a healthcare company has recalled 45,500 COVID-19 rapid tests due to a “high number of false positive reports.”

Pharmaceutical company Celltrion USA announced on February 28 it is recalling specific lots of the DiaTrust COVID-19 Ag Rapid Test due to the high number of false positive results.

The FDA said that a false positive test result can lead to a delay in “the correct diagnosis and treatment for the actual cause of a person’s illness.”

The COVID-19 rapid tests also displayed a shelf life of 18 months, but the FDA’s emergency use authorization states that the tests can only be used for 12 months.

“The use of the affected product could cause serious adverse health consequences and death,” the FDA webpage states.

Also on Wednesday (March 16), the FDA announced the recall of the SD Biosensor STANDARD Q COVID-19 Ag Home Test, stating the test is not approved by the FDA for marketing or distribution in the United States. The FDA said “there is not sufficient data demonstrating that the test’s performance is accurate,” which could lead to inaccurate results.

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