Events

Rappel de Chemistry Calibrator used with ADVIA Chemistry Systems Direct Bilirubin Assay (DBIL_2). 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 Healthcare Pty Ltd.

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-2016-RN-01374-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-10-18
  • 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-2016-RN-01374-1
  • 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 for several lots the currently assigned dbil_2 assigned calibrator values (acvs) may cause, on average, a positive proportional bias of approximately 41% on patient samples compared to the reference method for direct bilirubin measurement. quality control (qc) material is also affected by this issue. depending on the quality control concentrations and ranges used by the laboratory, quality control may not detect this issue. the positive bias may lead to an overestimation of direct bilirubin and the potential for further monitoring or confirmation of a potentially abnormal direct bilirubin finding during the assessment of liver dysfunction and/or during the investigation of jaundice. to correct the positive bias and restore alignment to the reference method, the acv for dbil_2 has been reassigned from 77 micromol/l to 55 micromol/l. all other analytes present in the chemistry calibrator meet product standards.
  • Action
    Siemens is advising users to use the reassigned DBIL_2 ACVs for the affected Chemistry Calibrator lot numbers. In addition, laboratories should review the targets and ranges for quality controls used with the DBIL_2.

Device

Chemistry Calibrator used with ADVIA Chemistry Systems Direct Bilirubin Assay (DBIL_2). An in vit...
  • Modèle / numéro de série
    Chemistry Calibrator used with ADVIA Chemistry Systems Direct Bilirubin Assay (DBIL_2). An in vitro diagnostic medical device (IVD).ADVIA Chemistry CalibratorSiemens Material Number (SMN): 10312279 Lot Numbers: 680726 (exp. 2017-06), 680726A (exp. 2017-09), 680726B (exp. 2017-09), 680726C (exp. 2018-02), 680726D (exp. 2018-02)ARTG Number: 185171
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA