Events

Recall of PENTRA 120 and PENTRA 120 Retic 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
    29700
  • Event Risk Class
    Class 2
  • Event Number
    Z-1342-04
  • Event Initiated Date
    2004-06-24
  • Event Date Posted
    2004-08-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-09-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34393
  • 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
    Stain, Reticulocyte - Product Code GJH
  • Reason
    Power failure having impact on software.
  • Action
    Firm sent a notification / recall letter and response card dated June 24,2004 and promised to provide software shortly.

Device

PENTRA 120 and PENTRA 120 Retic Hematology Analyzer
  • Model / Serial
    Any instrument which is not equipped with v4.55 or above will be upgraded.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    PENTRA 120 and PENTRA 120 Retic Hematology Analyzer
  • Manufacturer
    ABX Diagnostics Inc

Manufacturer

ABX Diagnostics Inc
  • Manufacturer Address
    ABX Diagnostics Inc, 34 Bunsen, Irvine CA 92618-4210
  • Source
    USFDA