Events

Recall of Device Recall ABL800 Flex Series 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
    46686
  • Event Risk Class
    Class 2
  • Event Number
    Z-1654-2008
  • Event Initiated Date
    2008-01-18
  • 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=67928
  • 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
    Human Blood Analyzer - Product Code CHL
  • Reason
    Reported calibration errors are not displayed on the analyzers parameter bar screen or on the patient results when the calibration number is between 32768 - 65535 and 98303 - 131070. this may cause the operator to perform measurements and obtain questionable results.
  • Action
    On February 28, 2008, a Field Action Notes Letter was issued advising them about a Mandatory Software Update. Customers were notified of the problem by fax and letter (Fed Ex). The Recall Letter instructed the user to disable the parameter bar feature and only rely on the traffic light system indicator which properly indicates system errors. The letter includes instructions to temporarily fix the problem and notice of a update of the software module that updates the parameter bar. If you have any questions contact Vincent Sigmund at (440)-871-8900 ext. 209.

Device

Device Recall ABL800 Flex Series Analyzer
  • Model / Serial
    ABL800 Flex (902-754)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA and Canada - Products were sold in all fifty (50) US States. including twenty-nine 29 government accounts and 138 Canadian accounts.
  • Product Description
    ABL800 FLEX Series Analyzer - Human Blood Analyzer (Laboratory Device)
  • Manufacturer
    Radiometer America Inc

Manufacturer

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