BEUDAMED
    FDA Recall Terminated

    iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland, Made in Germany.

    Recall: Z-1937-2019 · Initiated October 18, 2018

    Recall

    Recall Number
    Z-1937-2019
    Event Number
    82879
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    KQO
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    October 18, 2018
    Terminated
    November 10, 2020
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland, Made in Germany.

    Reason

    Falsely elevated (false positive) urobilinogen patient results due to an increase in the sensitivity of the urobilinogen reaction.

    Action

    The recalling firm issued letters dated 10/15/2018 on 10/18/2018 via email or regular mail for customers where an email was unavailable. The letter explains the issue and impact, and provides the actions the consignee is to take when using the product. The letter informed the customer they are actively working on a resolution to prevent recurrence of the issue.

    Distribution

    Distribution was nationwide, including Puerto Rico. There was also military/government distribution. Foreign distribution was made to Canada, Argentina, Brazil, Chile, Colombia, Mexico, Peru, Philippines, Singapore, and Taiwan.

    Quantity

    956,798/100 test strip vials