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 Beckman Coulter.

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 014 05 17 001
  • Event Initiated Date
    2017-10-31
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11700
  • 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, TGA :http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-01360-1
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    Following biases observed in the results of the french national quality controls, beckman coulter has been informed that a study completed by the french competent authority agence nationale de sécurité du medicament et des produits de santé (ansm) showed diagnosed cancer patients in non-remission of their metastatic disease, may have results below the upper reference limit (url) of 31.3 u/ml as stated in the access br monitor instructions for use (ifu).

Device

Access BR Monitor used with the Access Family of Immunoassay Systems
  • Model / Serial
    REF No.: 387620 LOT : All Non-Expired Lots and Future Lots
  • Product Description
    IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Manufacturers representative
    Al-Jeel Medical & Trading Co. LTD
  • Source
    SFDA