Events

Rappel de Elecsys Beta-CrossLaps. 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-2013-RN-00388-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-05-03
  • 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-00388-1
  • 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
    Roche is revising the package insert claims for the sample stability (serum and heparinised plasma) and biotin interference of elecsys beta-crosslaps. the package insert will be updated to reflect the results of recent internal testing for sample stability testing and biotin interference as follows:- the sample stability claim for serum kept at 20-25 degrees celcius will be revised from 8 hours to 6 hours- the sample stability claim for heparinised plasma kept at 20-25 degrees celcius will be revised from 24 hours to 4 hours- the sample stability claim for heparinised plasma kept at 4-8 degrees celcius will be revised from 24 hours to 8 hours. - the biotin interference claim "the assay should be unaffected by biotin up to 368nmol/l or 90 ng/ml" will be revised to "the assay should be unaffected by biotin up to 123nmol/l or 30ng/ml".
  • Action
    Roche Diagnostics are providing updated information that reflects the results of recent internal testing. A package insert update will include these changes from August, 2013.

Device

Elecsys Beta-CrossLaps. An in vitro diagnostic medical device (IVD)

Manufacturer

Roche Diagnostics Australia Pty Limited