BEUDAMED
    FDA Enforcement Class II Ongoing

    QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests

    Recall: Z-1636-2024 · Reported May 1, 2024

    Enforcement

    Recall Number
    Z-1636-2024
    Event ID
    94219
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Quidel Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 1, 2024
    Initiation Date
    March 5, 2024
    Classification Date
    April 24, 2024
    Address
    10165 McKellar Ct, N/A, San Diego, CA, 92121-4201, United States

    Description

    QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests

    Reason

    There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results, the positivite test line may not be visible/ hidden under the cassette of the test device thus potentially leading to a false negative result.

    Code Info

    UDI: 30014613336754/Lot # 162621 162695 162498 162718 162749 163025

    Distribution

    US: AK AL AR AZ CA CO CT DC FL GA HI IA ID IL IN KS KY LA MA MD MI MN MO MT NC ND NE NH NJ NV NY OH OK OR PA SC SD TN TX UT VA WA WI WV OUS: United Arab Emirates, Belgium, Canada, Chile, China, Germany, Spain, United Kingdom, Ireland, Italy, South Korea, Lithuania, Qatar

    Quantity

    104,300 units