Events

Rappel de ADVIA 120/2120/2120i Haematology Systems DIFF TIMEPAC Perox 1 Reagent. 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 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-00310-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-04-13
  • 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-2018-RN-00310-1
  • 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 confirmed that platelet clump flags (plt-clm) are generated in the perox channel of the advia 120/2120/2120i haematology system while running cbc/diff (complete blood count / differential) whole blood samples with diff timepac perox 1 reagent lot # 57211, in samples without platelet clumps. the accuracy of the platelet results are not impacted when the perox 1 reagent (lot 57211) is used on the system and a plt-clm flag is generated due to this issue. additionally, platelet results are reported from the red blood cell/platelet (rbc/plt) channel and not measured in the perox channel where platelet clumps are detected. however, the platelet results will be flagged if the clump count is greater than 300, directing the user to investigate the sample.
  • Action
    Siemens is requesting customers discontinue use of and discard the entire lot of ADVIA 120/2120/2120i DIFF TIMEPAC products listed in Table 1 of the Customer Letter. Complete and return the Response Form attached to the Customer Letter by Friday 20th April 2018 as confirmation that you have received and understood this Recall Action.

Device

ADVIA 120/2120/2120i Haematology Systems DIFF TIMEPAC Perox 1 Reagent. An in vitro Diagnostic Med...
  • Modèle / numéro de série
    ADVIA 120/2120/2120i Haematology Systems DIFF TIMEPAC Perox 1 Reagent. An in vitro Diagnostic Medical Device (IVD)Catalogue Number: SMN 10312270Lot Numbers: 74264,73839, 57211Expiration Date: 31/7/19 ARTG Number: 184207(Siemens Healthcare - Haematology full blood count IVDs)
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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