BEUDAMED
    FDA Recall Terminated

    UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317 H351 H373 H411 - Product Usage: System reagent for the quantitative determination of Unsaturated Iron Binding Capacity (UIBC) in human serum and plasma on Beckman Coulter AU analyzers.

    Recall: Z-3028-2020 · Initiated August 18, 2020

    Recall

    Recall Number
    Z-3028-2020
    Event Number
    86273
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    JMO
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 18, 2020
    Terminated
    September 8, 2021
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317 H351 H373 H411 - Product Usage: System reagent for the quantitative determination of Unsaturated Iron Binding Capacity (UIBC) in human serum and plasma on Beckman Coulter AU analyzers.

    Reason

    The manufacturer has identified that the use of Unsaturated Iron Binding Capacity (UBIC) lot 2690 will produce erroneously high patient results at the low end of the linear range.

    Action

    An Urgent Medical Device Recall letter was sent on 08/18/2020 to the affected customers via mail and/or email. The customers are advised to discontinue the use of UIBC lot 2690. When available, replace it with an unaffected lot of UIBC.

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of CA, FL and NJ. The countries of Algeria, Egypt, Philippines and Taiwan.

    Quantity

    219 units