Events

translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by Radiometer Medical.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Recall / Field Safety Notice
  • Event ID
    mdprc 034 07 13 000
  • Event Initiated Date
    2013-07-04
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=3882
  • Notes / Alerts
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Extra notes in the data
    Report Source: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company
  • Reason
    Radiometer has recently become aware that one lot of membrane boxes has been produced using an incorrect electrolyte solution. some of these membranes have been found to calibrate and provide valid results on the analyzer for a few days (4-6 days), before cal 2 fails on zero point. when this happens the membrane units will have a rapidly increasing positive bias until they are rejected by the following cal 2. cal 2 is run every 4 hours, and within this time slot there is a possible risk of obtaining wrong measuring results.

Device

IVD: Blood gas electrode, oxygen, pO2 membrane units for ABL5/50/500
  • Model / Serial
    D999 Membrane box for E909 pO2 electrode for ABL5/50/5XX, 942-042, R0971
  • Product Description
    An electrical conducting device used to determine the concentration of oxygen (O2) in a sample of blood
  • Manufacturer
    Radiometer Medical

Manufacturer

Radiometer Medical
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Manufacturers representative
    Salehiya Trading Est., Riyadh, (01) 2628939
  • Source
    SFDA