FDA recall Z-1009-2022

MESA BIOTECH, INC · Class I · device

Product

Accula SARS-CoV-2 Test, REF: COV4100

Reason for recall

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

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2022-04-06
Report date
2022-05-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1009-2022