Events

Recall of ABL80 FLEX SYSTEM - ANALYZER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by RADIOMETER MEDICAL APS.

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
    58313
  • Event Risk Class
    II
  • Event Initiated Date
    2012-02-02
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Possible condition in a limited of abl80 flex analyzers configured either flex or basic software which can cause the analyzer to report outside the published performance specifications for ph pco2 cna+ck+ cca2+ and ccl-. this condition can occur without indication to the user.

Device

ABL80 FLEX SYSTEM - ANALYZER
  • Model / Serial
    Model Catalog: 393-839 (Lot serial: 304157); Model Catalog: 393-839 (Lot serial: 304162 through to 305409); Model Catalog: 903-227 (Lot serial: 304160); Model Catalog: 393-839 (Lot serial: 304160); Model Catalog: 903-227 (Lot serial: 304157); Model Catalog: 393-839 (Lot serial: Signal Data Board >May 2011); Model Catalog: 903-227 (Lot serial: Signal Data Board >May 2011); Model Catalog: 903-227 (Lot serial: 304162 through to 305409)
  • Product Description
    ABL80 Flex (with FLEX or BASIC software)
  • Manufacturer
    RADIOMETER MEDICAL APS

Manufacturer

RADIOMETER MEDICAL APS