BEUDAMED
    FDA Enforcement Class II Terminated

    Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood Collection Card and Foil Bags Quantity 500 Cards and Foil Bags REF CMT01/F02 IFU: Advance Dx 100 SSE(Serum Separating Extraction) Technology BLOOD COLLECTION INSTRUCTIONS

    Recall: Z-2237-2021 · Reported August 18, 2021

    Enforcement

    Recall Number
    Z-2237-2021
    Event ID
    88281
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Advance Dx, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 18, 2021
    Initiation Date
    July 6, 2021
    Classification Date
    August 10, 2021
    Termination Date
    August 22, 2023
    Address
    11250 N 118th Way, N/A, Scottsdale, AZ, 85259-4149, United States

    Description

    Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood Collection Card and Foil Bags Quantity 500 Cards and Foil Bags REF CMT01/F02 IFU: Advance Dx 100 SSE(Serum Separating Extraction) Technology BLOOD COLLECTION INSTRUCTIONS

    Reason

    Due to high glucose test results when using the blood collection cards.

    Code Info

    Product Catalog Number: CMT01 GTIN: 1061C010890976 Lot Number: PPD02102 V6

    Distribution

    U.S. Nationwide distribution in the states of MD and NC.

    Quantity

    179,750 cards