Events

Rappel de N Latex ß2–Microglobulin

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-2015-RN-01054-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-11-02
  • 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-2015-RN-01054-1
  • 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 received complaints from customers not being able to establish a calibration curve or to validate an established calibration curve with the respective controls when using one of the affected lots of n latex ß2-microglobulin. the issue might lead to the inability to calibrate the assay or to obtain invalid test runs. however, patient results are not affected. there is the potential for the user to be exposed to assay components contaminated with pseudomonas libanensis, pseudomonas rhodesiae and pseudomonas extremorientalis. exposure may lead to an infection and its consequencesa review of previously generated results due to this issue is at the discretion of the laboratory.Siemens advises that the delay of results for these assays does not represent a hazard, and as a result the severity level is none or negligible.
  • Action
    Customers are asked to discontinue use of and discard the affected lots listed in the Customer Letter. A replacement or credit will be issued as per the normal procedure.

Device

N Latex ß2–Microglobulin
  • Modèle / numéro de série
    N Latex ß2–Microglobulin Catalogue Numbers: OQWU155 and OQWU15 Lot Numbers: 44862, 44902, 44968, 45192, 45229, 45252, 45291, 45329, 45342, 45366, 45470, 45525 and 45543. ARTG Number: 178153
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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