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MESA BIOTECH, INC recalls Accula SARS-CoV-2 Test, REF: COV4100
Recalled May 18, 2022 · FDA recall Z-1009-2022 · MESA BIOTECH
Hazard
SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment. · FDA Class I
Units
6162
Sold at
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.
Description
SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment.
Product
Accula SARS-CoV-2 Test, REF: COV4100
Manufacturer(s)
MESA BIOTECH, INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →