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 157 09 12 000
  • Event Initiated Date
    2012-09-25
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=2412
  • 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: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    If a user scans the insert barcode for lot 65 or higher and the analyzer was not upgraded to software v1.28 (or higher) then the scanned range for po2 will be incorrect. the analyzer will provide no warning that the range is incorrect.

Device

Blood gas analyzer,, ABL80 FLEX analyzer
  • Model / Serial
    A QUALICHECK4+ Level 4 (S7460) range study for the ABL80 with FLEX software Beginning with S7460 Lot 65, all ABL80 analyzers with FLEX software
  • Product Description
    Blood gas analyzer
  • Manufacturer
    Radiometer Medical

Manufacturer

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