Events

Recall of Device Recall ABX PENTRA 400 I.S.E. Module

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Horiba Instruments, Inc dba Horiba Medical.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    64723
  • Event Risk Class
    Class 2
  • Event Number
    Z-1141-2013
  • Event Initiated Date
    2013-03-20
  • Event Date Posted
    2013-04-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116862
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Electrode, ion specific, sodium - Product Code JGS
  • 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."

Device

Device Recall ABX PENTRA 400 I.S.E. Module
  • Model / Serial
    Model Numbers: P400ISE110EN02 and P400ISE110US02. All Serial Numbers. Versions 5.0.7 and below
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product 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.
  • Manufacturer
    Horiba Instruments, Inc dba Horiba Medical

Manufacturer

Horiba Instruments, Inc dba Horiba Medical
  • Manufacturer Address
    Horiba Instruments, Inc dba Horiba Medical, 34 Bunsen, Irvine CA 92618-4210
  • Manufacturer Parent Company (2017)
    Horiba Ltd.
  • Source
    USFDA