Events

Recall of ABL800 blood gas analyzer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Radiometer America 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
    35796
  • Event Risk Class
    Class 3
  • Event Number
    Z-1325-06
  • Event Initiated Date
    2005-10-31
  • Event Date Posted
    2006-08-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46889
  • 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
    blood gas analyzer - Product Code CHL
  • Reason
    Abl800 series blood gas analyzer became inoperable when the 'restore default setup' button was touched.
  • Action
    The firm initiated this recall on 10/31/2005, at which time a Field Action Note was issued to their Service Reps. The notice instructed the service personnel to upgrade all ABL800 analyzer units presently running with software version V5.21 to the new version V5.23, in order to correct this problem. The Service Personnel began conducting visits at each customer site on 10/31/2005.

Device

ABL800 blood gas analyzer
  • Model / Serial
    All ABL800 analyzers running software vers 5.21 i.e. ABL8xx 754R00xx N0xx
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA and Canada.
  • Product Description
    ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21.
  • Manufacturer
    Radiometer America Inc

Manufacturer

Radiometer America Inc
  • Manufacturer Address
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1598
  • Source
    USFDA