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 009 09 18 001
  • Event Initiated Date
    2018-09-26
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13221
  • 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
    Limit the use of coaguchek (xs pt, xs pt pst, and pt) strips calibrated with who reference standard rtf/16 to measuring range of 0.8 to 4.5 inr,.

Device

CoaguChek (XS PT, XS PT PST, and PT) strips
  • Model / Serial
    - Please check attachment for codes - ........................................................ NCMDR Update Codes: CoaguChek XS PT Test PST: 07671679xxx, 07671687xxx, 07762798xxx CoaguChek XS PT Test: 04625374xxx, 04625358xxx, 07797826xxx, 04625315xxx CoaguChek PT Test : 06688721xxx CoaguChek XS PT Test PST from #272167xx (S_303) up to #334498xx (S_343) CoaguChek XS PT Test from #272167xx (S_303) up to #334498xx (S_343) CoaguChek PT Test from #272170xx (S_054) up to #353606xx (S_061)
  • Product Classification
    Hematology and Pathology Devices
  • Product Description
    CoaguChek strips
  • Manufacturer
    Roche Diagnostics Corp

Manufacturer

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