Events

Rappel de ADVIA Centaur CP, XP, and XPT Systems with use of BNP and TSH3-Ultra

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Siemens Healthcare 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-00033-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-01-18
  • 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-2018-RN-00033-1
  • 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
    Siemens healthcare diagnostics has identified the following issues:- the advia centaur cp, xp and xpt systems will not expire the multi-diluent 15 pack at the end of the required 7-day on board stability (obs), if any of the affected bnp or tsh3ul lots are present on the system(s) when performing on-board dilutions; and.- on the advia centaur xpt only, the system becomes inoperable under the following scenario: 1) scanning the master curve card of advia centaur bnp kit lots ending in 193 or higher or advia centaur tsh3-ultra kit lots ending in 301 or higher, and 2) processing a bnp or tsh3ul onboard dilution of a sample. in this case, the system may display an “unknown state” message and requires customer action. when this error occurs, any tests that are in-process would have to be repeated.
  • Action
    Siemens is advising customers who use ALL ADVIA Centaur Systems: - Do not perform onboard dilutions on any ADVIA Centaur system if any of the affected product kit lots are present on the system - Onboard dilutions for the ADVIA Centaur BNP and/or TSH3UL assay(s) are only supported when using ADVIA Centaur BNP kit lots ending in 210 and above and ADVIA Centaur TSH3UL kit lots ending in 310 and above. For customers using ADVIA Centaur XPT Systems, if users intend to perform onboard dilutions for the ADVIA Centaur BNP and/or TSH3UL assays, users must restart the workstation after scanning the master curve card for the BNP and/or TSH3UL assay kit lot, before ordering an onboard dilution for these assays. For customers using ADVIA Centaur CP Systems, if any of the affected BNP kit lots or TSH3UL kit lots have been in use on the system, users must manually track the time that the Multi-Diluent 15 has been in use on board the system.

Device

ADVIA Centaur CP, XP, and XPT Systems with use of BNP and TSH3-Ultra
  • Modèle / numéro de série
    ADVIA Centaur CP, XP, and XPT Systems with use of BNP and TSH3-UltraIn vitro diagnostic medical devicesADVIA Centaur BNP (100 tests)Catalogue: 02816138 SMN Number: 10309044 Kit Lot Numbers ending in: 192,193,196 ADVIA Centaur TSH3-Ultra (100 tests) Catalogue: 06491072 SMN Numbers: 10282378 Kit Lot Numbers ending in: 298, 301ADVIA Centaur TSH3-Ultra (500 tests) Catalogue: 06491080 SMN Number: 10282378 Kit Lot Numbers ending in: 298,301ARTG Number 175075
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    DHTGA