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 Bio-Rad Medical 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 063 07 17 000
  • Event Initiated Date
    2017-07-17
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11308
  • 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
    It has come to our notice that for product id-papain, mal n° 005510, shows double population reactions when the auto-control is performed in papain one stage technique. it has been observed internally that in the last two weeks before expiry, the lots of papain mentioned above may not destroy these antigens as expected. there is no patient risk associated with this issue. the use of id-papain for compatibility testing and for the detection of antigens normally detected in the id-papain test is not impacted by this phenomenon and the papain can be used for this purpose.

Device

ID-Papain
  • Model / Serial
    Double population reaction Mat. n° : 005510 Loss of enzyme activity Mat. n° : 005510 Lot No IHD : 06311 961, 06311 97 1, 06311 991, 06311 02 1 Lot No SAP : 121302961, 124782971, 141517991, 145832021 Expiry Date : 03.07.2017, 17.07.2017, 31.07.2017, 14.08.2017
  • Product Description
    Immunohematology, ID-Papain
  • Manufacturer
    Bio-Rad Medical Diagnostics

Manufacturer

Bio-Rad Medical Diagnostics