FDA Provides Update on Mesa Biotech’s Recall of Its Accula COVID-19 Tests

The FDA has issued on update on Mesa Biotech’s April 6 recall of its Accula SARS-CoV-2 test, deeming it a Class 1 recall because of the risk of serious injury or death.

The Accula test is a polymerase chain reaction (PCR) test intended to detect SARS-CoV-2 based on a nasal swab sample. Certain lots of the test have an increased risk of giving false positive results due to contamination at the manufacturing facility, the agency said. The 6,177 affected products were manufactured between Dec. 30, 2021, and Jan. 23, and distributed from Jan. 19 to Feb. 8.

The FDA said it has received no reports of injuries, adverse health consequences or death associated with the products, but warned that false positive results could lead to further exposure of uninfected individuals to the SARS-CoV-2 virus.