Events

Rappel de AMM Flex Reagent Cartridge used with Dimension Clinical Chemistry System Assay: Ammonia (AMM)

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-2017-RN-00349-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-03-14
  • 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-00349-1
  • 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
    In september 2014, siemens healthcare diagnostics issued customer notification dc 14-09 that addressed a high rate of “abnormal assay” test report messages for its dimension ammonia (amm) assay. internal testing revealed that the “result monitor below” mean factor for ammonia (ammdf119) is set with a narrow limit, which may cause some ammonia results to be inappropriately flagged with an “abnormal assay”. flagged amm “abnormal assay” results may be attributed to a contamination of open wells of the amm flex reagent cartridge. quality control (qc) and patient samples may be affected; however, affected results are appropriately flagged.
  • Action
    Siemens is reducing the AMM open well stability from 3 days to 1 day (24 hours) and providing instructions for managing this change. Dimension AMM IFU revision E will reflect this change. The new version of Dimension software, 10.2, will do the following: - Automatically move to a new well every day. This decrease in the open well maximum duration reduces the amount of time the AMM reagent is exposed to any potential contaminates, reduces the need for customers to manually move to a new reagent well, and aids in the prevention of erroneous flagging. - Contain the Below Mean Factor limit of 0.90. Users are notified that until Dimension 10.2 software is installed on their instruments, manually move to a fresh AMM well of reagent every day. Also, to reduce the likelihood of false AMM “Abnormal assay” messages, verify that the Below Mean Factor for the Result Monitor is set to the revised limit of 0.90 by following instructions provided in the customer letter.

Device

AMM Flex Reagent Cartridge used with Dimension Clinical Chemistry System Assay: Ammonia (AMM)
  • Modèle / numéro de série
    AMM Flex Reagent Cartridge used with Dimension Clinical Chemistry System Assay: Ammonia (AMM)Catalogue Number: DF119Siemens Material Number (SMN):10711991Lot Numbers: All in-date lotsARTG Number: 181689
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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