BEUDAMED
    FDA Enforcement Class II Terminated

    HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Numbers, Software Versions 5.0.7 and Below. Used to measure absorbance and ion electrodes.

    Recall: Z-1141-2013 · Reported April 24, 2013

    Enforcement

    Recall Number
    Z-1141-2013
    Event ID
    64723
    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
    April 24, 2013
    Initiation Date
    March 20, 2013
    Classification Date
    April 18, 2013
    Termination Date
    September 26, 2014
    Address
    34 Bunsen, N/A, Irvine, CA, 92618-4210, United States

    Description

    HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Numbers, Software Versions 5.0.7 and Below. Used to measure absorbance and ion electrodes.

    Reason

    HORIBA Medical is informing all ABX PENTRA 400 Analyzer with I.S.E. Module customers that there are no Linearity Limit Flags for the I.S.E. assays currently programmed into the ABX PENTRA 400 Analyzer software. All other assays run on this analyzer do have Linearity Limit Flags to alert the user to values that fall below or above the validated linearity range for each assay.

    Code Info

    Model Numbers: P400ISE110EN02 and P400ISE110US02. All Serial Numbers. Versions 5.0.7 and below

    Distribution

    Nationwide Distribution.

    Quantity

    905 units