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 Gen Probe Incorporated.

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 140 09 12 000
  • Event Initiated Date
    2012-09-17
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=2395
  • 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: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    Anomalous decreases in the average optical density (00) have been observed with certain kits within the llfecode5 pak product line. we believe the decrease in od was caused by a chemical reaction with an unknown compound that was introduced into the manufacturing process when faulty vials supplied by a third party were used to contain the substrate buffer kit component.

Device

IVD, detection of autoantbodies LIFECODES PAK12, PAKAUTO & PAK2-LE
  • Model / Serial
    Catalogue number: PAK12, PAKAUTO & PAK2-LE (see attached)
  • Product Description
    IVD, detection of autoantbodies LIFECODES
  • Manufacturer
    Gen Probe Incorporated

Manufacturer

Gen Probe Incorporated
  • Manufacturer Parent Company (2017)
    Grifols Sa
  • Manufacturers representative
    Al-Jeel Medical & Trading Co. Ltd, Riyadh, (01) 4041717
  • Source
    SFDA