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 bioMerieux 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 092 07 18 000
  • Event Initiated Date
    2018-07-18
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12929
  • 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
    Following customers’ complaints for calibrations out of range (standard s1 out of range low and/or control c1 out of range high) when using vidas ca 15-3 lots 1006022590 and 1006251930, investigators confirmed a defect on the identified products and reproduced the issue reported by the customers.

Device

VIDAS CA 15-3
  • Model / Serial
    VIDAS CA 15-3 (Ref. 30429) lots 1006022590 and 1006251930
  • Product Description
    IVDs
  • Manufacturer
    bioMerieux Inc

Manufacturer

bioMerieux Inc