Events

Rappel de Dimension Tacrolimus (TACR) Flex Reagent Cartridge (An in vitro diagnostic medical device used with Dimension Clinical Chemistry Systems)

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-00340-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-04-17
  • 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-00340-1
  • 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
    Siemens has confirmed that the tacr method may demonstrate reduced on-board stability which may result in imprecise and inaccurate qc and patient results. investigations have shown that results may become imprecise when tacr flexes are stored on-board the instrument for 2 days or more. this imprecision typically presents as one or more elevated tacr results following a period of instrument inactivity. subsequent results from the same well may exhibit depressed values. the discordant high results may be elevated by as much as 2 times the expected value and the discordant low results may be depressed by as much as fifty percent. longer periods of on-board storage (> 2 days) coupled with periods of instrument standby may increase the magnitude of elevated and depressed results.
  • Action
    Siemens is asking customers to discard the remaining inventory of the affected stock. Also, Siemens is recommending discussing the issues with the laboratory director to determine if additional follow up is appropriate for TACR results reported in the laboratory. Beginning with TACR reagent cartridge lot BB4087, an “Alert Card” indicating that the on-board stability is limited to 8 hours, will be packaged with in the TACR cartons.

Device

Dimension Tacrolimus (TACR) Flex Reagent Cartridge (An in vitro diagnostic medical device used wi...
  • Modèle / numéro de série
    Dimension Tacrolimus (TACR) Flex Reagent Cartridge (An in vitro diagnostic medical device used with Dimension Clinical Chemistry Systems)Catalogue Number: DF107Lot Numbers: GB3099, GA3120, DB3141, GB3162, GB3176, FA3197, FA3267, FB3267ARTG Number: 182779
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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