Events

Rappel de ADVIA Chemistry Triglyceride Concentrated (TRIG_c) 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-2016-RN-01103-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-08-22
  • 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-2016-RN-01103-1
  • 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 the advia chemistry triglyceride concentrated reagent (trig_c) does not meet instructions for use (ifu) linearity claim at the upper limit of the assay range as it approaches the end of its shelf life. internal testing indicates that a patient bias (-7% to -12%) may be seen at concentration levels from 6.22 to 6.78 mmol/l. linearity is reduced by approximately 50% at triglyceride concentrations approaching the upper end of the extended range of 12.43 mmol/l.Quality control (qc) material may not detect this issue depending on the triglyceride concentrations in the qc material.Siemens internal testing has confirmed all other in date lots are currently meeting linearity ifu claims. however, as a precaution, until root cause is determined, a short term mitigation of reducing the expiration date to 6 months for all lots of advia chemistry systems triglyceride concentrated has been implemented.
  • Action
    Siemens is advising users to discontinue use and discard any remaining stock of lots 365096 and 379597. Discontinue use and discard remaining lots once they reach the revised shelf life. Customers will need to manually monitor the revised expiration dates for the impacted lots. A review of previously generated results is at the discretion on the Laboratory Director.

Device

ADVIA Chemistry Triglyceride Concentrated (TRIG_c) Reagent. An in vitro diagnostic medical device...
  • Modèle / numéro de série
    ADVIA Chemistry Triglyceride Concentrated (TRIG_c) Reagent. An in vitro diagnostic medical device (IVD)Catalogue Number: 10697575Lot Numbers: 365096, 379597, 379919, 379930, 379942, 379946, 376894ARTG Number:176642
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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