BEUDAMED
    FDA Recall Terminated

    iChemVELOCITY Strips, Catalog 800-7212

    Recall: Z-1535-2020 · Initiated February 17, 2020

    Recall

    Recall Number
    Z-1535-2020
    Event Number
    85047
    Firm
    Beckman Coulter, Inc.
    FEI Number
    3000203293
    Product Code
    KQO
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 17, 2020
    Terminated
    May 13, 2021
    Address
    11800 SW 147th Ave, Miami, FL, 33196-2500

    Description

    iChemVELOCITY Strips, Catalog 800-7212

    Reason

    The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips.

    Action

    An Urgent Medical Device Recall letter will be sent during the week of 02/17/2020 to the affected customers via email and mail. Customers are advised to discard the affected product and order a replacement from BEC.

    Distribution

    Distribution in US including Puerto Rico, Canada, and Taiwan

    Quantity

    10822 vials