Events

Rappel de Alere Cholestech LDX Multianalyte Control (An in vitro diagnostic medical device used to monitor the performance of total cholesterol (TC), high density lipoprotein (HDL), triglycerides (TRG), glucose (GLU), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) test procedures on the Alere Cholestech LDX System)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Inverness Medical Innovations Australia Pty Ltd T/A Alere.

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-2013-RN-00227-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-03-14
  • 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-2013-RN-00227-1
  • 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
    Investigations of the affected lot numbers have indicated that these lots of controls may yield results which are out of range high when tested with the alere cholestech ldx hdl test.
  • Action
    Inverness Medical Innovations (trading as Alere) is asking customers to discontinue the use of the affected lots and destroy all remaining stock. Customers have been advised that If the controls have been within the ranges shown on the value assignment card that came with the control materials, then the patient results should be considered clinically acceptable. Replacement product is expected to be available in approximately 4 – 6 weeks.

Device

Alere Cholestech LDX Multianalyte Control (An in vitro diagnostic medical device used to monitor ...
  • Modèle / numéro de série
    Alere Cholestech LDX Multianalyte Control (An in vitro diagnostic medical device used to monitor the performance of total cholesterol (TC), high density lipoprotein (HDL), triglycerides (TRG), glucose (GLU), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) test procedures on the Alere Cholestech LDX System)Catalogue Number: CT88769Lot Numbers: C2572, C2572A, C2593 & C2593AARTG Number: 160951
  • Manufacturer
    Inverness Medical Innovations Australia Pty Ltd T/A Alere

Manufacturer

Inverness Medical Innovations Australia Pty Ltd T/A Alere
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DHTGA