Events

Recall of Device Recall ABL 80 COOX SYSTEM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sendx Medical 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
    52791
  • Event Risk Class
    Class 2
  • Event Number
    Z-0150-2010
  • Event Initiated Date
    2009-02-20
  • Event Date Posted
    2009-11-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84010
  • 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
    Analyzer - Product Code CHL
  • Reason
    Inverness have recently become aware of a potential error contained in v1.30 and v1.31 software for the abl 80 co-ox platform. the error can occur if the analyzer is set to automatically upload patient records to radiance or an his/lis system. this can result in the reporting of incorrect results for one or more co-ox derived parameters. incorrect results can be displayed on the screen and the.
  • Action
    Radiometer sent out a letter to consignees informing them of public reason for recall, and telling them that they have provided a copy of the upgrade software and instructions to correct this potential problem immediately. Software upgrade instructions were included with the recall letter. Consignees were informed that if they preferred that their local service representative perform the upgrade, to follow the Instructions for disabling auto upload of patients records. SOFTWARE UPGRADE INSTRUCTIONS: The upgrade software must be installed via the Software Upgrade option under Menu>Utilities>Software Upgrade. It is not a "boo table" CD. ~The Upgrade process will take approximately 10 minutes. The analyzer should be allowed to complete the entire process without user interaction. Do not attempt to turn the analyzer on or off manually at any time during the process. ~The upgrade process will include the following general steps: 1. Automatic power down and reboot of the analyzer 2. File transfer process which includes a variety of progress bars to communicate the status 3. Automatic power down and reboot of the analyzer a second time 4. A dialog box on the main menu screen that states, "ABL80 FLEX software has been upgraded to version 1.32." This signifies a successful upgrade process. ~If a solution pack and a sensor cassette are already installed on the analyzer, their installation status will not be affected by the software upgrade. ~All stored data will be retained in all logs They were also asked to complete and return the attached fax form, with their signature, to 1-800-736-0601. If their were any questions regarding the letter, or upgrade, to contact Techline at 1-800-736-0600 opt.

Device

Device Recall ABL 80 COOX SYSTEM
  • Model / Serial
    Model Number: 393-841 all serial numbers are affected.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Domestically and Worldwide: Germany, France, Spain, United Kingdom, Poland, Austria, Italy, Tokyo, Australia, and Denmark Domestically to OH
  • Product Description
    ABL 80 CO-OX SYSTEM, software versions 1.30 and 1.31 || Additional Product Codes: CEM, CGA, CGZ, GHS, GKR, GLY, JFP, JGS, JIX, JJY, JPI || The ABL 80 CO-OX SYSTEM is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL 80 CO-OX SYSTEM is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
  • Manufacturer
    Sendx Medical Inc

Manufacturer

Sendx Medical Inc
  • Manufacturer Address
    Sendx Medical Inc, 1945 Palomar Oaks Way, Carlsbad CA 92009-1307
  • Source
    USFDA