BEUDAMED
    FDA Enforcement Class II Ongoing

    COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs.

    Recall: Z-2620-2023 · Reported September 27, 2023

    Enforcement

    Recall Number
    Z-2620-2023
    Event ID
    92832
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Copan Diagnostics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 27, 2023
    Initiation Date
    July 14, 2023
    Classification Date
    September 20, 2023
    Address
    26055 Jefferson Ave, Murrieta, CA, 92562-6983, United States

    Description

    COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs.

    Reason

    Due to plastic defects, the pipette aspiration capability potentially doesn't meet the expected tolerance

    Code Info

    UDI-50841467100545 / Lot Codes: B104661 B202918 B203404 B203405 B204186 B204187 B204819 B204820 B300133 B300410 B300608 B300647 B300679 B301129 B301133 B301135 B301134

    Distribution

    US: CA OUS: None

    Quantity

    2,592 units