Events

Rappel de Roche Cobas Sysmex SP-10/ SP-1000 and associated transport systems (AlphaN, HST and XN-9000/3000)

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Roche Diagnostics GmbH.

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
    19796
  • Date de mise en oeuvre de l'événement
    2016-02-27
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • Cause
    There have been reports overseas that sample tubes may not be correctly placed back in the rack tube transport (rtt) after the de-capping process. this may result in open tubes being dropped within the cobas p 512 pre-analytical system, contaminating the system and potentially other samples. a false triggering or detection of the “ready” signal from the lifting gripper in the decapper causes the system to register that the motor motion is finished. the system then continues with the next process step and opens the gripper prematurely., this issue may lead to contamination of the instrument and other samples. the risk to operator of contamination is less than remote. however, the contamination of other samples may lead to erroneous sample results with possible inappropriate diagnosis/treatment.
  • Action
    Software to be upgraded

Device

Roche Cobas Sysmex SP-10/ SP-1000 and associated transport systems (AlphaN, HST and XN-9000/3000)
  • Modèle / numéro de série
    Model: , Affected: Part Nos: BR362571 and 04303413
  • Manufacturer
    Roche Diagnostics GmbH

Manufacturer

Roche Diagnostics GmbH