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 Roche Diagnostics Corp.

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 025 09 18 000
  • Event Initiated Date
    2018-09-12
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13133
  • 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
    Roche diagnostics is committed to continuously increase cyber security of its products. as part of this effort, we plan to release software updates that could prevent or reduce risk of products being exploited by cyber attackers. potential risks of cyber-attack include compromised system confidentiality, availability and integrity.

Device

Cybersecurity updates in Accu-Chek Inform II system,
  • Model / Serial
    Accu-Chek Inform II system CoaguChek Pro II system CoaguChek XS Plus system CoaguChek XS Pro system cobas h 232 POC system cobas h 232 POC system (scanner version)
  • Product Description
    Clinical chemistry substrate IVDs
  • Manufacturer
    Roche Diagnostics Corp

Manufacturer

Roche Diagnostics Corp
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Manufacturers representative
    FAROUK, MAAMOUN TAMER & COMPANY
  • Source
    SFDA