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 092 10 18 000
  • Event Initiated Date
    2018-10-18
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13344
  • 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 complaints received for gens 26 and 27, as well as internal testing of a new lot, ortho observed negatively biased results. an investigation determined that gens 26 and 27 are negatively biased by approximately 15 to 20 mg/dl (0.38 to 0.51 mmol/l) across the measuring range.

Device

VITROS Chemistry Products dLDL Reagent
  • Model / Serial
    Product Code: 6801728 Affected Generations (GENs): GENs 26 & 27 Expiry Date: 6-NOV-2018 through 7-May-2019
  • Product Description
    Automation Systems, Laboratory
  • 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