Quidel Remembers Lyra Covid Check Due To Excessive Danger Of False Adverse Outcomes
A person inquires in a cell check automobile in Brooklyn, New York, the USA, Jan.
Brendan McDermid | Reuters
Quidel is recalling its Lyra Covid-19 assay check resulting from a excessive threat of false adverse ends in sufferers who even have excessive ranges of the virus.
Quidel is an organization that makes diagnostic well being merchandise worldwide. The Covid check obtained emergency approval from the Meals and Drug Administration in March. It makes use of a swab pattern from the nasal space to detect RNA that’s particular for the SARS-CoV-2 virus.
“False-negative outcomes can result in delayed analysis or insufficient therapy of SARS-CoV-2, which might hurt the affected person, trigger severe sickness and loss of life,” the FDA wrote on its web site saying the recall.
False adverse outcomes might additionally unfold the virus additional right into a neighborhood, placing others at excessive threat of harm or loss of life.
Quidel has obtained 5 complaints in regards to the product, however there are at the moment no experiences of harm or loss of life from its use. The corporate’s inventory plunged round 5% in after-hours buying and selling.