BEUDAMED
    FDA Enforcement Class II Terminated

    ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)

    Recall: Z-0902-2015 · Reported January 14, 2015

    Enforcement

    Recall Number
    Z-0902-2015
    Event ID
    69773
    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
    January 14, 2015
    Initiation Date
    November 13, 2014
    Classification Date
    January 2, 2015
    Termination Date
    March 19, 2015
    Address
    34 Bunsen, N/A, Irvine, CA, 92618-4210, United States

    Description

    ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)

    Reason

    HORIBA Medical is recalling the ABX PENTRA 400 Reagent Container because they 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. The defect would result in a false high or false low results for HbA1c and false high results for magnes

    Code Info

    Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL) manufactured since June 2014.

    Distribution

    Nationwide in US

    Quantity

    443 units