Events

Recall of ABL80 FLEX SYSTEM - SP80 - SOLUTION PACK

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
    18771
  • Event Risk Class
    III
  • Event Initiated Date
    2011-04-26
  • 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
    Affected lots of solution packs were produced with a wrong conductivity value encoded into the chip. this causes a minor negative bias for the hct (hematocrite) measurement of 1 to 2% and following failure of the air detection system.

Device

ABL80 FLEX SYSTEM - SP80 - SOLUTION PACK
  • Model / Serial
    Model Catalog: 944-309 (Lot serial: 62785); Model Catalog: 944-174 (Lot serial: 62785); Model Catalog: 944-309 (Lot serial: 63718 63864); Model Catalog: 944-174 (Lot serial: 63718 63864); Model Catalog: 944-309 (Lot serial: 63480 63620); Model Catalog: 944-174 (Lot serial: 63480 63620); Model Catalog: 944-309 (Lot serial: 62718 62784); Model Catalog: 944-174 (Lot serial: 62871 63038); Model Catalog: 944-309 (Lot serial: 62871 63038); Model Catalog: 944-174 (Lot serial: 63134 63390); Model Catalog: 944-309 (Lot serial: 63134 63390); Model Catalog: 944-174 (Lot serial: 62718 62784)
  • Product Description
    Solution packs to ABL80 Basic/Flex
  • Manufacturer
    RADIOMETER MEDICAL APS

Manufacturer

RADIOMETER MEDICAL APS