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 Ortho-Clinical Diagnostics.

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 094 08 18 000
  • Event Initiated Date
    2018-08-29
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13092
  • 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
    Under very specific circumstances, incorrect positioning of the sample metering proboscis on a vitros 5600 integrated system may cause an insufficient sample volume to be dispensed onto a microslide without suppressing the potentially incorrect result.

Device

VITROS 5600 Integrated System
  • Model / Serial
    1) VITROS 5600 Integrated System: - Product Code: 6802413 - Software Versions: 3.3.1 and Below 2) VITROS 5600 Integrated System Refurbished: - Product Code: 6802915 - Software Versions: 3.3.1 and Below
  • Product Description
    Automation Systems, Laboratory
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Manufacturer Parent Company (2017)
    The Carlyle Group LP
  • Manufacturers representative
    Samir Photographic Supplies Co. Ltd.
  • Source
    SFDA