Events

Rappel de CoaguChek HS Plus/Pro System. 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-2017-RN-01181-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2017-09-13
  • 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-2017-RN-01181-1
  • 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
    It has been identified that very occasionally, the coaguchek® xs plus meter or coaguchek® xs pro meter may power off when removed from the external power supply or handheld base unit if using the rechargeable handheld battery pack. due to a software error in the handheld battery pack the meter may sporadically go into an error mode, with the meter subsequently powering off. this issue affects only those battery packs in the range serial number uu100000 to uu109415 (batch number 05604041 to 05705151) with software revision 20 (please note: the revision number is printed on the outer package of the handheld battery pack; it is not visible on the battery pack itself). if this issue occurs, the battery pack should be removed and then reinserted to reboot the meter. the meter will then work correctly after reboot. alternatively, if not connected to the lis, the meter may be used with 4 aa batteries and the standard battery compartment cover.
  • Action
    1. If this issue occurs, the battery pack should be removed and then reinserted to reboot the meter. The meter will then work correctly after reboot. Alternatively, if not connected to the LIS, the meter may be used with 4 AA batteries and the standard battery compartment cover. 2. Contact Roche Diagnostics Australia via the call centre on 1800 645 619 to arrange for a replacement battery pack, quoting the reference number QN-CPS-2017-174. 3. Retain this letter in a prominent place in your laboratory for at least one month. 4. Acknowledge receipt of the notification, using the supplied link or reply directly to Roche Diagnostics Australia by email at australia.qra@roche.com to confirm your receipt of this notification.

Device

CoaguChek HS Plus/Pro System. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    CoaguChek HS Plus/Pro System. An in vitro diagnostic medical device (IVD)CoaguChek XS Plus systemMaterial Number: 04800842190CoaguChek XS Pro systemMaterial Number: 05530199190Handheld battery packMaterial Number: 04805640001Serial Number / BatchesSerial Number range: UU100000 to UU109415Batch Numbers: 05604041 to 05705151ARTG Number 197926
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited