Events

Recall of ABX Diagnostices Pentra 60C+ Hematology Analyzer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ABX Diagnostics Inc.

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
    26431
  • Event Risk Class
    Class 3
  • Event Number
    Z-1149-03
  • Event Initiated Date
    2003-06-04
  • Event Date Posted
    2003-08-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27671
  • 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
    Counter, Differential Cell - Product Code GKZ
  • Reason
    Instrument fails to obtain correct patient information/results due to malfunction of the equipment's sample door.
  • Action
    The firm distributed a 'Product Advisory Note' on June 5, 2003 by mail which includes instructions on how to avoid problems. It also mentions a new software release which will fix the problem.

Device

ABX Diagnostices Pentra 60C+ Hematology Analyzer
  • Model / Serial
    Software versions of up to 1.7
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    ABX Diagnostices Pentra 60C+ Hematology Analyzer
  • Manufacturer
    ABX Diagnostics Inc

Manufacturer

ABX Diagnostics Inc
  • Manufacturer Address
    ABX Diagnostics Inc, 34 Bunsen Drive, Irvine CA 92618
  • Source
    USFDA