Events

Rappel de epoc BGEM Test Card (blood gas, electrolyte and metabolite test card panel), 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 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-00289-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-04-03
  • 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-00289-1
  • 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
    The manufacturer has determined that the referenced lots of this product may yield results that are not consistent with stated precision performance criteria at concentration values at the high-end range of glucose test sensor. specifically, in test cards aged to within 2.5 months (75 days) of their expiration date, a negative bias between of 15 – 30 % has been observed in sample with glucose levels greater than 22 mmol/l. all glucose measurements between the low end of the reportable range and 22 mmol/l are accurately reported, as are all other assay results in the affected cards.
  • Action
    Alere is instructing end users to discontinue the use of, and to destroy, any remaining affected units. Unaffected kits will be provided to customers by Alere to replace the recalled units.

Device

epoc BGEM Test Card (blood gas, electrolyte and metabolite test card panel), An in vitro diagnost...
  • Modèle / numéro de série
    epoc BGEM Test Card (blood gas, electrolyte and metabolite test card panel), An in vitro diagnostic medical device (IVD).Catalogue Number: CT-1004-00-00Lot Numbers: 07-12289-00 & 07-01263-00ARTG Number: 198588
  • 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