Events

translation missing: fr.activerecord.attributes.event.titles.recall_field_safety_notice

Selon Saudi Food & Drug Authority, ce/cet/cette translation missing: fr.activerecord.attributes.event.types.recall_field_safety_notice concerne un dispositif en/au/aux/à Saudi Arabia qui a été fabriqué par Siemens Healthcare Diagnostics.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Recall / Field Safety Notice
  • ID de l'événement
    mdprc 095 12 18 001
  • Date de mise en oeuvre de l'événement
    2018-12-24
  • Pays de l'événement
    Saudi Arabia
  • Source de l'événement
    SFDA
  • URL de la source de l'événement
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13675
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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...
  • Modèle / numéro de série
    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
  • Description du dispositif
    Instrument/analyser IVDs
  • Manufacturer
    Siemens Healthcare Diagnostics

Manufacturer

Siemens Healthcare Diagnostics
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Représentant du fabricant
    ABDULREHMAN AL GOSAIBI GTB
  • Source
    SFDA