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 077 10 15 001
  • Event Initiated Date
    2016-12-08
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=10354
  • 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 conftrmed high and/or out-of-range values for tnc on control level 1, for the kits and vials listed in the table at the end of this notice, when compared to the published table of expected results.

Device

COULTER Body Fluid Control Level 1
  • Model / Serial
    COULTER Body Fluid Control Kit PN 628030, Level 1 ........................ NCMDR update codes : Kit: 4511690K Control: 183231620 Kit: 4511700K Control: 183231630 Kit: 4511710K Control: 183231630 Kit: 4511720K Control: 183231630 Kit: 4511730K Control: 183231630 Kit: 4511740K Control: 183231640 Kit: 4511750K Control: 183231650 Kit: 4511760K Control: 183231660 Kit: 4511770K Control: 183231660
  • Product Description
    Blood Cell Counter
  • Manufacturer
    Beckman Coulter

Manufacturer

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