NEW YORK – The US Food and Drug Administration said on Monday that it has classified Mesa Biotech's recent recall of its Accula SARS-CoV-2 test as a Class I recall, the most serious type, because use of the device may cause serious injuries or death.
On April 6, Mesa had sent a product recall letter to all customers who had received certain lots of the test kits, instructing them to stop using them and discarding or returning their remaining inventory. The company issued the recall, which involved 6,177 devices in the US, because these lots had an increased risk of yielding false positive results due to contamination at the manufacturing facility.
The FDA said that "although there have been no reports of injuries, adverse health consequences, or death associated with the use of these affected products, false positive results could lead to further exposure of uninfected individuals to SARS-CoV-2 virus."
The Accula SARS-CoV-2 test is a PCR test intended to detect SARS-CoV-2 based on a nasal swab. It received Emergency Use Authorization from the FDA in March 2020 and has been authorized for use in point-of-care settings.
Mesa Biotech was acquired by Thermo Fisher Scientific in February 2021 for up to $550 million.