Recall of Device Recall ABL90 FLEX Blood 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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Potassium Ion Specific Electrode - Product Code CEM
  • Reason
    Due to a software error, a patient mix up can occur on the abl90. if a sample is pre-registered and the sample "fails" the next result will inherit the patient data from the previous result.
  • Action
    On 11/16/10 the firm sent Medical Device Field Correction letters to their customers. The letter states that all systems will be upgraded and until each system is upgraded, they instructed their customer to "always query for patient ID prior to introducing the sample." They also instruct each customer to complete the "Fax Return Form" acknowledging receipt of the letter. If customers have questions regarding the letter or the upgrade, they should contact Technical Support at 1-800-736-0600 Opt 4.


  • Model / Serial
    S/N 393-090R0059N007, 393-090R0061N008 & 393-090R0061N009
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution -- USA, including states of MI, NJ, & PA and countries Australia, Austria, Belgium, Denmark, Finland, France, Germany, Indonesia, Italy, Japan, Kuwait, Malaysia, Netherlands, Norway, Poland, Russia, Spain, Sweden, Switzerland, United Arab Emirates & United Kingdom.
  • Product Description
    ABL90 FLEX Blood Analyzer Part Number: 393-090. || Intended for use by trained technologists, nurses, physicians and therapists and for use in a laboratory environment, near patient or point-of-care setting. Also, Intended for in vitro testing of samples of heparinized whole blood.
  • Manufacturer


  • Manufacturer Address
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145
  • Manufacturer Parent Company (2017)
  • Source