BEUDAMED
    FDA Recall Terminated

    10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400

    Recall: Z-0493-2018 · Initiated November 21, 2017

    Recall

    Recall Number
    Z-0493-2018
    Event Number
    78692
    Firm
    Horiba Instruments, Inc dba Horiba Medical
    FEI Number
    3002698356
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 21, 2017
    Terminated
    November 4, 2019
    Address
    34 Bunsen, Irvine, CA, 92618-4210

    Description

    10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400

    Reason

    The ABX PENTRA Reagent Containers do not always sit properly into the reagent rack. In low reagent level scenarios, this could lead to insufficient reagent volume being pipetted and could lead to incorrect results being reported without an alarm.

    Action

    The firm initiated their recall by letter on 11/21/2017. The letter stated the following: "A new production of reagent container compliant for each reference is under process and will be made available very soon. In the meantime and to allow a proper operating of the analyzer ABX PENTRA 400 / PENTRA C400, it Is necessary to push the reagent containers in the reagent racks until they touch the bottom of the rack. Please share this information with your laboratory staff, and retain this notification as part of your Quality System documentation. It is mandatory for you to complete and return the enclosed response form within 10 days so we may maintain our records."

    Distribution

    Nationwide

    Quantity

    10 bags, 100 units each