Events

Recall of ABL800 FLEX SYSTEM - INSTRUMENT CONFIGURATIONS

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
    85565
  • Event Risk Class
    II
  • Event Initiated Date
    2017-01-11
  • 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
    On the abl800 series analyzers the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous". the selected sample type is displayed correctly on the analyzer itself. however irrespectively of the sample type selected on the analyzer during sample processing the analyzer will transmit the less specific sample type "cord blood" to a his/lis or middleware system.

Device

ABL800 FLEX SYSTEM - INSTRUMENT CONFIGURATIONS
  • Model / Serial
    Model Catalog: 393-801 (Lot serial: Version 6.14); Model Catalog: 393-800 (Lot serial: Version 6.14)
  • Product Description
    ABL800 FLEX SYSTEM
  • Manufacturer
    RADIOMETER MEDICAL APS

Manufacturer

RADIOMETER MEDICAL APS