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.

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 047 05 12 000
  • Event Initiated Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    Siemens healthcare diagnostics has confirmed that the presence of intrinsic factor blocking antibody (ifba) in some patients can result in a false and significant elevation in the reported concentration of vitamin b12 on the dimension vista® system. siemens’ data indicate that the elevation is highly variable, and in some cases, values below the cutoff for b12 deficiency (i.E. 254 pg/ml) were reported as greater than 2000 pg/ml. this issue affects all lots of b12 flex® reagent cartridges (k6442) on the dimension vista® system. this issue does not affect patients who do not have ifba.



  • Manufacturer Parent Company (2017)
  • Manufacturers representative
  • Source