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 Thermo Fisher Scientific Inc..

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 087 11 17 000
  • Event Initiated Date
    2017-11-26
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11791
  • 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
    An internal technical investigation has determined that thermo scientific™ remel™ shigella sonnei (phases 1&2) agglutinating serum (lots listed above) may fail to agglutinate within the specified minimum reaction time when tested with shigella sonnei phase 2 bacteria. continued use of these lots may result in a failure to correctly identify isolates as shigella sonnei phase 2.

Device

Thermo Scientific Remel Shigella sonnei (Phases 1&2) Agglutinating Serum
  • Model / Serial
    Product code: R30164201 Bottle lot No. Carton lot No 1465528 : 1465529 1847290 : 2118879, 2194099, 2173683, 2161363, 1984639, 2149414, 2135578 1738565 : 1738564, 1971308, 1957305, 1947930, 1847285, 1738566
  • Product Description
    Shigella sonnei (Phases 1&2) Agglutinating Serum
  • Manufacturer
    Thermo Fisher Scientific Inc.

Manufacturer

Thermo Fisher Scientific Inc.
  • Manufacturer Parent Company (2017)
    Thermo Fisher Scientific Inc
  • Manufacturers representative
    Medical supplies & Services Co.Ltd Mediserv
  • Source
    SFDA