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 076 10 15 000
  • Event Initiated Date
    2015-10-21
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=8392
  • 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
    Beckman coulter has confirmed that the dxh 800 and dxh 600 systems' volume, conductivity, scatter and multiple angle of light scatter (vcsn) preamp board can produce an intermittent high electrical noise on the upper median angle light scatter (umals) measurement, which may cause a low recovery of reticulocyte percentage (ret %) and absolute number (ret#) results.

Device

UniCel DxH 800 & 600 COULTER Cellular Analysis Systems
  • Model / Serial
    UniCel® DxH 800 COULTER® Cellular Analysis Systems, PN 629029, B24465 and B24802 UniCel® DxH 600 COULTER® Cellular Analysis System,.PN B23858
  • Product Description
    Analyzers, Laboratory, Clinical Chemistry/Immunoassay
  • Manufacturer
    Beckman Coulter

Manufacturer

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