Events

Rappel de Bond Ready-to-Use Primary Antibody and Probe kits used with Bond Polymer Refine Detection Kit. 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 Leica Microsystems 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-00069-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-01-18
  • 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-00069-1
  • 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
    Leica biosystems recently became aware that the product / detection kit combinations identified may not provide adequate staining when used according to the instructions for use. if the products are used according to their instructions for use with appropriate positive controls, the failure to adequately stain would be apparent to the user on the control tissue and on the patient tissue. the absence of adequate staining of tissue is likely to result in a delay in obtaining the results of ihc / ish staining and, in a worst-case scenario, could cause a delay in the diagnosis or classification of a neoplasm.
  • Action
    Leica Biosystems is advising users to discontinue use of the listed antibodies / probes with the specified detection kits. There are alternative kits available for use. Leica is advising that there is no requirement for a review of previously reported results if appropriate positive controls were used.

Device

Bond Ready-to-Use Primary Antibody and Probe kits used with Bond Polymer Refine Detection Kit. An...
  • Modèle / numéro de série
    Bond Ready-to-Use Primary Antibody and Probe kits used with Bond Polymer Refine Detection Kit. An in vitro diagnostic medical device (IVD)Multiple antibody and probes affectedProduct Codes: PA0552,PA0210,PB0614,PB0589,PB0645,PB0669,PB0809,PB0785All lot numbers affectedAffected Bond Polymer Refine Detection KitsProduct Code: DS9800Lot Numbers: 42314,42388,42474,42486,42499,42555,42570,42579,42627,42645,42683,42780,42802,42823,42852,43050Expiry Dates: 02 April 2017 to 21 May 2017
  • Manufacturer
    Leica Microsystems Pty Ltd

Manufacturer

Leica Microsystems Pty Ltd