Events

Recall of Device Recall ABL 800 FLEX 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
    36812
  • Event Risk Class
    Class 3
  • Event Number
    Z-1095-2007
  • Event Initiated Date
    2006-11-13
  • Event Date Posted
    2007-07-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49393
  • 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 analyzers - Product Code CHL
  • Reason
    Software anomaly. protein removing program incorporated in the operating software for versions: v3.833 and v5.24, of the abl700 and abl800 blood gas analyzers, may allow for protein build up on the electrode membranes of blood gas analyzers. this condition can influence analyzer results. when the protein removal program is run too frequently, more than once a week, or when running the protein rem.
  • Action
    The firm issued a 'Safety Alert Notice' [FAN 915-248] to all customers which received the recalled ABL700 and ABL800 Analyzers equipped with the referenced software. The 11/13/2006 notice describes the problem concerning the Protein Removal program to the user/customers and emphasizes that the frequency of running the program in these software versions must be no more than once a week in order to prevent the protein build-up problem. It also contains additional recommendations for the user/customers for operation of these analyzer and informs the customers that a Radiometer Service Rep. will be coming out and making a software upgrade to these systems within the next few weeks. The alert notification is accompanied by a 'FAX FORM' to be signed and completed by each customer in order to verify that the alert notification has been received and that the staff members responsible for operating and maintaining the analyzer(s) on-site have been informed of this situation and that the necessary changes in the Operator's Manual concerning the Cleaning, Protein Removal, and Decontamination programs have been made.

Device

Device Recall ABL 800 FLEX analyzers
  • Model / Serial
    ABL 800 FLEX series blood gas analyzers containing software version 5.24.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The recalled analyzers were distributed to customers nationwide throughout the U.S. and in some parts of Canada.
  • Product Description
    ABL 800 FLEX series blood gas analyzers containing software version 5.24.
  • Manufacturer
    Radiometer America Inc

Manufacturer

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