MESA BIOTECH, INC recalls Accula SARS-CoV-2 Test, REF: COV4100

Recall date

April 6, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1009-2022

FDA classification

Class I

Brand / firm

MESA BIOTECH, INC

Sold / distributed

US Nationwide distribution in the states of CA, TX, MA, NY, FL, NC, NJ, GA, CO, HI, PA, WA, NY, VA, MD, KY, WI, IL, PR, ND, MI, TN, AZ, UT.

Why it was recalled

SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Accula SARS-CoV-2 Test, REF: COV4100