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 029 09 18 001
  • Event Initiated Date
    2018-11-21
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13518
  • 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: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=167891
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    Siemens healthcare diagnostics has confirmed lot-to-lot variability for qc and patient results when using the dimension® lipl lots listed in table 1. not all laboratories will observe this issue. the lot-to-lot bias observed for patient samples using the dimension® lots when compared with a control lot could be as high as 29%.

Device

Lot-to-Lot Variability When Using Dimension® Lipase (LIPL)
  • Model / Serial
    Flex® reagent cartridge lots GD9002, GA9003, GB9032 and GA9038 ………………………………. FDA update codes: Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745 Lot Numbers: 18128BA, 18172BA, 18186BB
  • Product Description
    Dimension clinical chemistry system
  • Manufacturer
    Siemens Healthcare Diagnostics GmbH

Manufacturer

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