Events

Recall of Device Recall Blood Gas and CoOx Electrolyte & Metabolyte Analyzers

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
    34953
  • Event Risk Class
    Class 2
  • Event Number
    Z-1317-06
  • Event Initiated Date
    2005-06-17
  • Event Date Posted
    2006-08-02
  • 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=45000
  • 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
    Software defect. po2 and pco2 sample test results run on the firm's abl700/800 series blood gas analyzers are not being properly flagged during the sample calibration phase.
  • Action
    The customers were apprised of this situation with a recall letter issued by the firm on 6/17/2005. In addition, new Operators Manuals were sent to the customers. In the letter, the customers were advised that a Service Engineer would be contacting them shortly in order to arrange for the installation of the software upgrade. The firm''s Service Engineers visited each customer location and installed software upgrades. Version 3.831 software was installed on the 700 Series Analyzers and Version 4.14 was installed on the 800 Series Analyzers. According to the firm, these software corrections were verified as having been completed by 3/10/2006.

Device

Device Recall Blood Gas and CoOx Electrolyte & Metabolyte Analyzers
  • Model / Serial
    All analyzers manufactured from 1/1999-12/2005. The devices contain serial numbers 902-441RxxxNxxx. The Rxxx number denotes manufacturing run, and the Nxxx number denotes the individual instrument within the run.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-700 series.
  • Manufacturer
    Radiometer America Inc

Manufacturer

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