Events

Recall of Device Recall ABX Pentra 120,120R,120DX

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
    35719
  • Event Risk Class
    Class 3
  • Event Number
    Z-1334-06
  • Event Initiated Date
    2006-03-24
  • Event Date Posted
    2006-08-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46682
  • 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
    automated hematology analyzer - Product Code GKZ
  • Reason
    Labels can be incorrectly placed on a sample tube resulting in a possible error in results attributed to a sample.
  • Action
    Notifications have been prepared advising that following an occurrence observed outside of the United States, HORIBAABX is providing information regarding the rare circumstance of a label being incorrectly placed on a sample tube, resulting in a possible error in results attributed to a sample. The March 24, 2006, letter identifies various conditions in which the anomaly occurs. In order to prevent this type of incident, the firm recommends that the customer ensure that the identification label is firmly attached to the sample tubes during their positioning or removal from the racks.

Device

Device Recall ABX Pentra 120,120R,120DX
  • Model / Serial
    All serial numbers, all software versions.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    ABX Pentra 120,120R,120DX, automated hematology analyzer
  • Manufacturer
    ABX Diagnostics Inc

Manufacturer

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