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.

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 095 12 18 001
  • Event Initiated Date
    2018-12-24
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13675
  • 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, http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01590-1
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    Siemens healthcare diagnostics has identified an issue with millipore water purification module (wpm) progard pretreatment packs when used with the dimension vista triglyceride assay. an investigation by siemens identified the potential for patient and quality control (qc) triglyceride results to be erroneously elevated as a result of contamination introduced by the millipore progard pretreatment pack’s filter fibres. a positive bias of up to 1.38 mmol/l has been observed. the potential for falsely elevated results could occur when processing the triglyceride assay immediately following the change of the progard pretreatment pack in the millipore wpm. siemens is not recommending a review of previously generated results.

Device

Dimension Vista Intelligent Lab Systems using a Progard Pretreatment Pack on the onboard Millipor...
  • Model / Serial
    Product: Millipore Progard Pretreatment Pack Siemens Material Number (SMN): 10450564 Lot Numbers: F7MA56608, F7MA50339, F7NA62488, F8AA93567, F8HA64477, F8AA13966, F8HA79819, F8BA20457, F8BA35774, F8DA59251, F8HA91305, F8JA97876, F8MA06374 ........................ TGA update codes: Dimension Vista Lab Systems: 10488217, 10488224, 10444802, 10459469
  • Product Description
    Instrument/analyser IVDs
  • Manufacturer
    Siemens Healthcare Diagnostics

Manufacturer

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