Health regulator recalls COVID-19 tests over false-positive results

*Abbot Molecular, Inc. says it recalls the false-positive results of Coronavirus tests that could wrongly tell consumers that they are infected by COVID-19 even if they actually are not

Alexander Davis | ConsumerConnect

Sequel to the agency’s discovery of false information contained in some Coronavirus tests, the United States (US) Food and Drug Administration (FDA) has upgraded a recall for certain COVID-19 tests made by Abbot Molecular, Inc. to the Class I designation, marking it as the most serious type of recall.

It was gathered the company recalled the tests early September 2021, after discovering that they could sometimes give false-positive results.

By implication, the test could tell a consumer that they are infected by COVID-19 even if they actually are not.

Besides, a false-positive result could lead to a delayed diagnosis of another disease or condition, unnecessary treatment for COVID-19, and this further spread of the virus if the person is put in close proximity to others who do have COVID-19 infection.