Events

Rappel de PTS Panels CHOL+GLU test strips. 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 Point Of Care Diagnostics Australia 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-2018-RN-00254-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-03-27
  • 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-2018-RN-00254-1
  • 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
    This recall is being conducted due to the potential for loss of activity of the glucose analyte prior to the full stated shelf life (august 2018).Based on the results of internal testing, there is potential for under-recovery of the glucose analyte, and therefore, potential for lower glucose test results. this issue may result in the delay in diagnosis of diabetes. there have been no adverse events reported in conjunction with this product.
  • Action
    Point of Care Diagnostics (PTS) is advising users to inspect stock and quarantine any remaing kits of the affected lots. Affected stock is to be destroyed. PTS will issue replacement product or a credit note.

Device

PTS Panels CHOL+GLU test strips. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    PTS Panels CHOL+GLU test strips. An in vitro diagnostic medical device (IVD)Reference Number: 1765Lot Number: A705 and A707Expiry Date: August 2018Unique Device Identification Code: Lot Numbers: A705: (01)00381931765016(17)180813(10)A705Lot Numbers: A707: (01)00381931765016(17)180828(10)A707ARTG Number: 252292(Point Of Care Diagnostics Australia - Clinical chemistry substrate IVDs)
  • Manufacturer
    Point Of Care Diagnostics Australia Pty Ltd

Manufacturer

Point Of Care Diagnostics Australia Pty Ltd