Events

Rappel de PreciControl ClinChem Multi 1 Lot No. 174787 & 174794 PreciControl ClinChem Multi 2 Lot No. 174801 & 174801(Potentially all lots are affected; this issue is easily detected as the QC will be elevated. Patient samples are not affected.)

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-2015-RN-00957-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2015-09-25
  • 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-2015-RN-00957-1
  • 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 has received a number of complaints that the recovery of c-reactive protein gen. 3 (crpl3) was too high in precicontrol clinchem multi 1 (pccc1), and especially in precicontrol clinchem multi 2 (pccc2), seen mainly on the cobas c 501 module. roche diagnostics has investigated and determined that the last three reagent lots showed higher recovery for all control materials. to resolve this issue a revised target value assignment procedure was necessary. target values for currently available pccc1 and pccc2 control lots have been adjusted – as per the tables given in the customer letter.
  • Action
    Target values for currently available PCCC1 and PCCC2 control lots have been adjusted – as per the tables given in the Customer Letter. Users are requested to use these revised values. This action has been closed-out on 04/03/2016.

Device

PreciControl ClinChem Multi 1 Lot No. 174787 & 174794 PreciControl ClinChem Multi 2 ...
  • Modèle / numéro de série
    PreciControl ClinChem Multi 1 Lot No. 174787 & 174794 PreciControl ClinChem Multi 2 Lot No. 174801 & 174801(Potentially all lots are affected; this issue is easily detected as the QC will be elevated. Patient samples are not affected.)ARTG number: 216332
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited