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 AG.

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 001 05 11 000
  • Event Initiated Date
    2011-05-01
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=363
  • 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: http://www.sfda.gov.sa/En/MedicalEquipments/recalls/NCAR+Brief.htm
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    The manufacturer has observed that test profiles on the ih-1000 analyzer, when id-diaclon anti-d is included, may generate incoherent results in the group of tests contained in the profile.

Device

Blood grouping system, automated
  • Model / Serial
    IH-1000 analyzer in combination with ID-DiaClon Anti-D.
  • Product Description
    An automated blood screening system.
  • Manufacturer
    DiaMed AG

Manufacturer

DiaMed AG
  • Manufacturer Parent Company (2017)
    Bio-Rad Laboratories Inc
  • Manufacturers representative
    Al Nahir Trading Co, Riaydh, (01) 4770444
  • Source
    SFDA