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 ThermoFisher Scientific.

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 001 05 12 000
  • Date de mise en oeuvre de l'événement
    2012-05-01
  • 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=1782
  • 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
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    Whole blood samples (either fresh or frozen) for hba1c testing are pre-treated with multigent hemoglobin denaturant. the pre-treated samples are placed on the architect csystems and tested for glycated hemoglobin (hba1c) and total hemoglobin (thb) concentrations. according to the package insert, pretreated samples must be allowed to incubate for a minimum of 5 minutes at 15 to 30 °c prior to testing. pretreated samples are stated to be stable for “up to 8 hours at 15 to 30 °c and up to 48 hours if stored at 2 to 8 °c”. however, recent studies have demonstrated that hba1c measurements increase with time after the samples are pre-treated. therefore, it is necessary to change the handling instructions for pre-treating samples for the multigent hba1c assay. the investigation to determine root cause is ongoing.

Device

Reagent, MULTIGENT Hemoglobin A1c Reagent
  • Modèle / numéro de série
    CATALOG NO.: 02K96-20; LOT NO.: All lots within expiry date
  • Description du dispositif
    Used in clinical laboratories for the quantitative in vitro measurement of percent HbA1c (HbA1c fraction) in human whole blood on the ARCHITECT cSystems and the AEROSETSystem. The HbA1c assay is intended to aid in the monitoring of long-term blood glucose control and compliance in individuals with diabetes mellitus.
  • Manufacturer
    ThermoFisher Scientific

Manufacturer

ThermoFisher Scientific
  • Société-mère du fabricant (2017)
    Thermo Fisher Scientific Inc
  • Représentant du fabricant
    Ebrahim M. Al-Mana & Bros. Co. Ltd., Riyadh, (01) 4610733
  • Source
    SFDA