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 Abbott.

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 124 07 18 000
  • Event Initiated Date
    2018-07-24
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12962
  • 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
    The architect pressure monitoring system helps identify errors during pipetting operations, and error messages are generated to alert the user, should a problem with this system occur. if the system is in the running status when pressure monitoring error code 3586 to 3600 or 5381 is generated, the architect takes appropriate action to protect the integrity of patient test(s). if communication is lost between the architect and the pressure monitoring system, the processing module will be placed into the stopped status until the issue can be addressed. this ensures all tests are monitored by the pressure monitoring system.

Device

ARCHITECT c4000, c8000 and c16000 Processing Module
  • Model / Serial
    ARCHITECT c4000 Processing Module : 02P24 ARCHITECT c8000 Processing Module : 01G06 ARCHITECT c16000 Processing Module : 03L77
  • Product Description
    Instrumentation
  • Manufacturer
    Abbott

Manufacturer

Abbott
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Manufacturers representative
    Medical supplies & Services Co.Ltd Mediserv
  • Source
    SFDA