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 Ltd.

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 113 02 17 000
  • Event Initiated Date
    2017-02-28
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=10732
  • 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
    Discrepant information between the previous versions 4.2.1 and 5.0 cobas® 8000 operator’s manuals (om) for non-standard tubes (nsts). the version 5.0 om incorrectly states that 11 to 16 mm diameter nsts may be used on cobas e 602 and cobas e 801 modules. however, only nst diameters of 13 to 16 mm are permitted on these modules.

Device

cobas e 602 module and cobas e 801 module used with cobas® 8000 modular analyzer series
  • Model / Serial
    GMMI / Part No.: 05990378001, 07682913001
  • Product Description
    In vitro diagnostic devices
  • Manufacturer
    Roche Diagnostics Ltd

Manufacturer

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