BEUDAMED
    FDA Enforcement Class II Terminated

    15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PENTRA C400

    Recall: Z-0494-2018 · Reported February 7, 2018

    Enforcement

    Recall Number
    Z-0494-2018
    Event ID
    78692
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Horiba Instruments, Inc dba Horiba Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 7, 2018
    Initiation Date
    November 21, 2017
    Classification Date
    January 31, 2018
    Termination Date
    November 4, 2019
    Address
    34 Bunsen, Irvine, CA, 92618-4210, United States

    Description

    15 ML REAGENT CUP, B1037307, SAP 1221037307 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.

    Code Info

    DATE - MVT 25.08.2017

    Distribution

    Nationwide

    Quantity

    10 bags of 100 units