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 DiaMed 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 068 06 13 000
  • Event Initiated Date
    2013-06-16
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=3751
  • 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
    In some specific conditions, inconsistent grading between the results in the well/card and the results returned by the ih-1 000 may be observed. after deep investigations, confirm that in these very specific conditions, positive reactions might be read as negative by the system due to the analysis algorithm of the images. therefore, this issue might lead to a wrong result released to the host if all the 3 following conditions are met: 1. a result is returned as negative while the reaction is positive, dp, or requires a human interpretation . 2. this negative result is consistent with the global interpretation of the test. 3. the system is configured without the second reading function activated for all tests results.

Device

IVDs,blood transfusion instrumentation, IH-1000
  • Model / Serial
    Product name: IH-1000 Product REF: 001000 IH-1000 software version: All version
  • Product Description
    IVDs, blood transfusion instrumentation
  • Manufacturer
    DiaMed GmbH

Manufacturer

DiaMed GmbH
  • Manufacturer Parent Company (2017)
    Bio-Rad Laboratories Inc
  • Manufacturers representative
    Al Nahir Trading co , Riyadh , (011)4770444
  • Source
    SFDA