BEUDAMED
    FDA Recall 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 · Initiated March 20, 2013

    Recall

    Recall Number
    Z-1141-2013
    Event Number
    64723
    Firm
    Horiba Instruments, Inc dba Horiba Medical
    FEI Number
    3002698356
    Product Code
    JGS
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 20, 2013
    Posted
    April 18, 2013
    Terminated
    September 26, 2014
    Address
    34 Bunsen, Irvine, CA, 92618-4210

    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.

    Action

    A recall letter, Field Safety Notice & Acknowledgement mailed to the customers March 20, 2013. The letter included the product information, reason for recall, instructions on what to do with the recalled product, and contact information:"If you have any questions or concerns, please contact your local HORIBA Medical representative. We sincerely apologize for any inconvenience this may cause your laboratory. Please contact your Customer Service Representative at 1-888-903-5001 (option 3) for any additional questions related to this customer letter."

    Distribution

    Nationwide Distribution.

    Quantity

    905 units