BEUDAMED
    FDA Enforcement Class II Ongoing

    a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy Test Urine Sample 30 Tests, Model Number: 92210. b. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere hCG Dipstick Fertility Test hCG Pregnancy Test Urine Sample 50 Tests Model Number: 92211.

    Recall: Z-1606-2022 · Reported August 31, 2022

    Enforcement

    Recall Number
    Z-1606-2022
    Event ID
    90336
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Mckesson Medical-Surgical Inc. Corporate Office
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 31, 2022
    Initiation Date
    May 25, 2022
    Classification Date
    August 25, 2022
    Address
    9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, VA, 23233, United States

    Description

    a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy Test Urine Sample 30 Tests, Model Number: 92210. b. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere hCG Dipstick Fertility Test hCG Pregnancy Test Urine Sample 50 Tests Model Number: 92211.

    Reason

    Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

    Code Info

    GTIN: a. 10815845020130; 00815845020133. b. 10815845020093, 00815845020096

    Distribution

    US Nationwide

    Quantity

    a. 5 kits b. 12 kits