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 Ortho-Clinical 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 103 07 18 002
  • Event Initiated Date
    2019-01-09
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13721
  • 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: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=169497
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    The purpose of this notification is to inform you that ortho clinical diagnostics determined that biased results may occur for specific vitros immunodiagnostic products (microwell assays) at biotin concentrations which are lower than indicated in the current instructions for use (ifu).

Device

VITROS MicroWell Assays
  • Model / Serial
    VITROS Immunodiagnostic Products Folate Reagent Pack (10758750009237) : 1513266 VITROS Immunodiagnostic Products Free PSA Reagent Pack (10758750013517) : 6842845 VITROS Immunodiagnostic Products FSH Reagent Pack (10758750000302) : 1931922 VITROS Immunodiagnostic Products Prolactin Reagent Pack (10758750000111) : 1849793 VITROS Immunodiagnostic Products TSH Reagent Pack (10758750000227) : 1912997 ………………………. Swissmedic Update code: VITROS Immunodiagnostic Products NT-proBNP Reagent Pack (10758750002061) : 6802156 ………………………. FDA update codes: VITROS HBeAg Reagent, Cat. No 6801819 VITROS Anti-HBe Reagent Pack, Cat No. 6801816 All expired, in-date, and future lots released.
  • Product Description
    IVDs
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics
  • Manufacturer Parent Company (2017)
    The Carlyle Group LP
  • Manufacturers representative
    Samir Photographic Supplies Co. Ltd.
  • Source
    SFDA