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 Siemens Healthcare Diagnostics GmbH.

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 062 04 18 000
  • Event Initiated Date
    2018-04-11
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12448
  • 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
    Siemens healthcare diagnostics has confirmed that the urea nitrogen reagent kit lots listed in the table 1 above for use on advia® 1800, 2400 and xpt chemistry systems demonstrate an increased incidence of calibration failures. results cannot be generated by the system when calibration fails. if calibration passes, there is a potential for falsely elevated patient and quality control results.

Device

ADVIA Chemistry Systems Urea Nitrogen (UN)
  • Model / Serial
    Catalog number: 03040257 Siemens Material Number: 10309051 Lot Number: 408143 Exp Date 28/06/2018 Lot Number: 418290 Exp Date 28/06/2018
  • Product Description
    Urea Nitrogen
  • Manufacturer
    Siemens Healthcare Diagnostics GmbH

Manufacturer

Siemens Healthcare Diagnostics GmbH
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Manufacturers representative
    ABDULREHMAN AL GOSAIBI GTB
  • Source
    SFDA