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 SENTINEL CH. SpA.

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 120 09 15 000
  • Event Initiated Date
    2015-09-27
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=8295
  • 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
    Due to a manufacturing issue with multigent ammonia ultra reagent, list number 6k89-30, lot 50083y600 is being removed from use. this lot is producing results below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes. quality control results are not affected.

Device

Ammonia Ultra Reagent
  • Model / Serial
    List Number (LN): 6K89-30 Lot Number: 50083Y600 Expiration Date: 31 Jul 2016
  • Product Description
    Reagent
  • Manufacturer
    SENTINEL CH. SpA

Manufacturer

SENTINEL CH. SpA
  • Manufacturer Parent Company (2017)
    Sentinel Ch. Spa
  • Manufacturers representative
    Medical supplies & Services Co.Ltd Mediserv
  • Source
    SFDA