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 Beckman Coulter.

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 091 04 16 000
  • Event Initiated Date
    2016-04-24
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=9223
  • 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
    The dxh 800, dxh 600, and dxh slidemaker stainer may fail to notify the user of warnings or error conditions for low or depleted reagent conditions, daily checks failures, lis disconnection, and printer failures at: -the alert status icon(s) on the system manager -the audible alarm at the system manager -the instrument beacon on the specimen processing module or slidemaker stainer the failure may occur when the system manager application is restarted or powered off/on.

Device

DxH 800, DxH 600, and DxH Slidemaker Stainer
  • Model / Serial
    PRODUCT : UniCel DxH 800 Coulter Cellular Analysis System REF : 629029, B24465, B24802, B68304 SOFTWARE VERSION : 2.0.0.0 and greater PRODUCT : UniCel DxH 600 Coulter Cellular Analysis System REF : B23858 SOFTWARE VERSION : 1.0.0.0 and greater PRODUCT : UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System REF : 775222 SOFTWARE VERSION : 1.5.0.0 and greater
  • Product Description
    IVD
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Manufacturers representative
    Al-Jeel Medical & Trading Co. LTD
  • Source
    SFDA