Events

Recall of Device Recall ABX PENTRA ML

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
    67528
  • Event Risk Class
    Class 2
  • Event Number
    Z-1173-2014
  • Event Initiated Date
    2014-02-14
  • Event Date Posted
    2014-03-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125675
  • 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
    Calculator/data processing module, for clinical use - Product Code JQP
  • Reason
    Horiba medical initiated this recall of all software versions of abx pentra ml (model a11a06152) due to a software bug with the potential of transmitting incorrect results to the laboratory information system.
  • Action
    Horiba sent an "URGENT SAFETY NOTICE letter datedFebruary 13, 2014 via by mail to customers. The letter identified the affected product, issue, impact, actions to be taken. Customers were instructed to share this information with laboratory staff and retain this notification as part of their laboratory documentation. Customers were requested to complete and return the enclosed response form via one of the following methods: Fax: 949-453-0600 Email: jim.knowles@horiba.com Mail: HORIBA Medical Attention: Jim Knowles, Recall Coordinator 34 Bunsen Drive Irvine, CA 92618. For questions contact your local Horiba Medical representative.

Device

Device Recall ABX PENTRA ML
  • Model / Serial
    Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Shelf Life: N/A
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution
  • Product Description
    Device Name: ABX PENTRA ML || Model/Part #(s): A11A01652 || Lot/Serial #(s): N/A || Software Version(s): All versions are subject to this correction. || Product Usage: || The ABX PENTRA ML is a software data management system intended for use on ABX Hematology Analyzers.
  • 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