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.
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.
information about this recall, click on the red button "Read
BACKGROUND: 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
RECOMMENDATIONS: On April 6,
2022, Mesa Biotech issued a Product Recall letter to all customers who
received the identified lots of Accula SARS-CoV-2 test kits. Customers
were instructed to:
using test kits from the identified lots
or return remaining inventory from the identified lots
were also asked to return a customer reply form acknowledging receipt
and understanding of the issue.