Mesa Biotech is recalling the Accula SARS-CoV-2 Test because certain lots of the test have an increased risk of giving false positive results due to contamination at the manufacturing facility, according to an FDA alert.

The Accula SARS-CoV-2 Test is a polymerase chain reaction (PCR) test intended to detect the presence of SARS-CoV-2, the virus that causes COVID-19, based on a nasal swab sample from patients. The sample is collected by healthcare providers or by people swabbing themselves under the guidance of a healthcare provider. This test is authorized for use in point of care (POC) settings. The sample is processed using special PCR laboratory equipment.

The FDA says no reports of injuries, adverse health consequences, or deaths have been reported, but noted false positive results could lead to further exposure of uninfected individuals to SARS-CoV-2 virus.

Recalled Product Info

  • Product Name: Accula SARS-CoV-2 Test
  • Product Codes: QJR
  • Lot Numbers: See recall database entry
  • Manufactured Dates: December 30, 2021 to January 1, 2022; January 15, 2022 to January 23, 2022
  • Distribution Dates: January 19, 2022 to February 8, 2022
  • Devices Recalled in the U.S.: 6,177
  • Date Initiated by Firm: April 6, 2022

Customers were instructed to stop using test kits from the identified lots and to discard or return remaining inventory from the identified lots.

More information is available on the FDA website.


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RT delivers in-depth coverage of the clinical, regulatory, and technology landscape for respiratory therapy—and reaches more than 28,000 key decision-makers and influencers. As one of healthcare’s most important data companies, we facilitate the rapid adoption of medical devices and practice management tools into the industry.