Events

Rappel de PreciControl Varia when used with Elecsys Parathyroid Hormone (PTH) assay on the cobas e 411 analyser. 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 Roche Diagnostics Australia Pty Limited.

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-01623-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-12-15
  • 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-2016-RN-01623-1
  • 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
    The barcode and value sheet for a single lot of precicontrol varia contain an erroneous target value for control level 2, when used with certain lots of elecsys pth assay on cobas e 411 analyser. the deviation between the correct & erroneous value is 20% for pth lot 185000 & 31% for pth lot 143251. this issue can be detected because it will cause elevated level 2 control recoveries. also it can be detected if both control levels 1 & 2 are run prior to measurement of patient samples. if only control level 2 is used and a local issue occurs in the lab where false-low pth results of -20% to -31% are obtained, the control would be within range and consequently false-low results could be reported. in an intra-operative measurement scenario, an erroneous low pth result can result in an incorrect conclusion that tumour resection was complete. in the worst case, remaining cancerous or hyperplastic tissue may be left undetected. to date, no customer complaints have been received by roche.
  • Action
    Roche is providing users with the correct control level 2 target values for the PTH assay on an updated value sheet. The correct target value is to be manually entered by the user, noting there is a reagent lot-specific value for Elecsys PTH lot 143251 and for other lots the PTH value target value should be used as per routine operation. This action has been closed-out on 25/05/2017

Device

PreciControl Varia when used with Elecsys Parathyroid Hormone (PTH) assay on the cobas e 411 anal...
  • Modèle / numéro de série
    PreciControl Varia when used with Elecsys Parathyroid Hormone (PTH) assay on the cobas e 411 analyser. An in vitro diagnostic medical device (IVD).PreciControl Varia Material Number: 05618860190Lot Number: 18928501Elecsys PTH assayMaterial Number: 11972103122Lot Number: 185000, 143251ARTG Number: 216332
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited