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 Laboratories 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 058 04 12 000
  • Event Initiated Date
    2012-04-17
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=1689
  • 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
    Explanation the purpose of this communication is to provide instructions on actions your laboratory must take regarding a single lot of architect stat troponin-i reagent. this issue is specific for lot 74264un11. abbott has confirmed that architect stat troponin-i, lot 74264un11 is demonstrating a shift in expected results in some cases. this effect can vary from kit to kit. all levels of abbott controls will detect the shift. if controls are out of range, performing a recalibration will restore the controls in range and accurate results would be generated. as described in the architect stat troponin-i package insert, it is recommended that each control level be tested once every 24 hours each day of use. an investigation is in process. initial indications suggest that the issue is caused by depressed relative light unit (rlu) values.

Device

Reagents, ARCHITECT STAT Troponin-I
  • Model / Serial
    List Number 2K41-28, Lot 74264UN11
  • Product Description
    Reagents
  • Manufacturer
    Abbott Laboratories Inc

Manufacturer

Abbott Laboratories Inc
  • 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
    Abbott Diagnostics Division
  • Source
    SFDA