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 Siemens Healthcare Diagnostics GmbH.

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 035 12 18 000
  • Event Initiated Date
    2018-12-11
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13591
  • 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
    Siemens identified a positive bias with atellica im atg kit lots ending in 317 and lower when compared to the standardization to world health organization (who) reference preparation mrc 65/93 stated in the instructions for use (ifu).

Device

Atellica IM Anti-Thyroglobulin (aTG) Positive Bias
  • Model / Serial
    Atellica IM aTG (100 test kit) : 10995461 Lots: 72259303 87903305 94908307 96439307 16824309 25822309 28942311 55978313 70389317 Atellica IM aTG (500 test kit) : 10995462 Lots: 56683313 70390317
  • Product Description
    IVDs
  • Manufacturer
    Siemens Healthcare Diagnostics GmbH

Manufacturer

Siemens Healthcare Diagnostics GmbH
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Manufacturers representative
    ABDULREHMAN AL GOSAIBI GTB
  • Source
    SFDA