Events

Rappel de ARCHITECT Lactic Acid. 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 Abbott Australasia Pty Ltd Diagnostic Division.

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-01359-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-10-24
  • 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-01359-1
  • 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
    Negative interference has been detected from the drug n-acetyl cysteine (nac) used with the architect lactic acid reagent (ln 9d89-21). the customer letter identifies the levels of interference observed at nac concentrations of 80 mg/l (0.49 mmol/l) and 800 mg/l (4.9 mmol/l). patients undergoing treatment with nac may have falsely depressed lactic acid results. a falsely depressed result may lead a physician to mistakenly rule out lactic acidosis.
  • Action
    Take into account the newly provided interference levels when using the device. This action has been closed out on 14 June 2017.

Device

ARCHITECT Lactic Acid. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    ARCHITECT Lactic Acid. An in vitro diagnostic medical device (IVD)List Number: 9D89-21Lot Number: 31497UN14 Expiry: 17-Oct-2016Lot Number: 09353UN15 Expiry: 12 Feb 2017Lot Number: 45216UN15 Expiry: 12 May 2017Lot Number: 14596UN15 Expiry: 30 Jul 2017Lot Number: 37055UN15 Expiry: 12 Oct 2017Lot Number: 14782UN16 Expiry: 21 Apr 2018ARTG Number: 185778
  • Manufacturer
    Abbott Australasia Pty Ltd Diagnostic Division

Manufacturer

Abbott Australasia Pty Ltd Diagnostic Division
  • 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