BEUDAMED
    FDA Enforcement Class I Ongoing

    Accula SARS-CoV-2 Test, REF: COV4100

    Recall: Z-1009-2022 · Reported May 18, 2022

    Enforcement

    Recall Number
    Z-1009-2022
    Event ID
    90013
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MESA BIOTECH, INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 18, 2022
    Initiation Date
    April 6, 2022
    Classification Date
    May 6, 2022
    Address
    6190 Cornerstone Ct E Ste 220, N/A, San Diego, CA, 92121-4701, United States

    Description

    Accula SARS-CoV-2 Test, REF: COV4100

    Reason

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

    Code Info

    UDI/DI: B540COV41000; P22006-026, P22010-021, P22024-023, P22024-030, P22026-006, P22026-012, P22026-016 , P22010-001, P22010-030, P22024-026, P22024-032, P22026-007, P22026-013, P22026-017 , P22010-017, P22010-032, P22024-027, P22026-002, P22026-008, P22026-014, P22026-019 , P22010-019, P22024-021, P22024-028, P22026-004, P22026-009, P22026-015, P22032-011

    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.

    Quantity

    6162