Events

Rappel de Dimension Clinical Chemistry Systems HB1C Flex Reagent Cartridge (An in vitro diagnostic medical device (IVD))

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Siemens Ltd Diagnostics Division.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2013-RN-00316-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-04-15
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00316-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Issue 1 - siemens healthcare diagnostics have confirmed a positive bias for values below 6%, there is a positive bias of 0.3% with an upper 95% confidence interval of 0.7%.The issue may impact quality control (qc) materials, patient samples, and proficiency survey samples. issue 2 - siemens healthcare diagnostics have confirmed a higher frequency of "above assay range" flags. there is a higher frequency of flags is related to higher recoveries of sample haemoglobin (hb) values (hb >25g/dl or >15.5mmol/l). the hb value is used to calculate the final output hba1c ratio (% hba1c [mmol/mol] result. results are suppressed (not reported) with the "above assay range" flag.
  • Action
    Siemens is asking users to destroy affected lots and will replace any recalled units.

Device

Dimension Clinical Chemistry Systems HB1C Flex Reagent Cartridge (An in vitro diagnostic medical ...
  • Modèle / numéro de série
    Dimension Clinical Chemistry Systems HB1C Flex Reagent Cartridge (An in vitro diagnostic medical device (IVD))Catalogue Number: DF105ASiemens Material Number (SMN): 10483822Lot Number: GA3009, GA3141, GA3197, GA3247, GA3113, GA3162, GB3211, GA3267, GA3134, GA3169, GA3232, GB3281, GC3302ARTG number: 181689
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA