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 BD Diagnostic Systems.

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 084 03 11 000
  • Event Initiated Date
    2011-03-21
  • Event Country
  • Event Source
    SFDA
  • 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: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company
  • Reason
    Bd has determined a low-level contamination with coagulase-negative staphylococci of the above mentioned product. microtrol discs are 1st generation derivatives from the original freeze dried vial of the atcc, nctc, ncyc or cip culture providing a quick and reliable source of control micro-organisms of known reaction. due to the presence of coagulase-negative staphylococci in addition of candida albicans, users may get incoherent reactions when performing their test method controls.

Device

  • Model / Serial
    Cat. Number 254625 Lot Number: 420061 420064
  • Product Description
    IVD General Diagnostics
  • Manufacturer

Manufacturer