Events

Rappel de Architect Toxo IgM Assay

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-01517-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-11-24
  • 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-01517-1
  • 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
    Abbott diagnostics has identified an issue with the architect toxo igm assay where an increase in grayzone and/or false reactive results have been observed for samples from immunocompromised patients or newborns as well as cord blood samples for certain lot numbers. these sample types share the commonality of low total igm titer. internal studies with the architect toxo igm assay have shown that pregnant women samples and serum and plasma blood donor samples are not impacted and meet assay specificity claims.Assay sensitivity is not impacted. there is the potential for false reactive patient results that may be due to reduced specificity in low total igm titer samples (eg. samples from immunocompromised patients or newborns or cord blood samples).
  • Action
    Users are advised to review the letter with their Medical Director. Additional testing with a secondary method is recommended to confirm reactive results (= 0.60 Index or = 1.00 S/CO) for samples from immunocompromised patients or newborns or cord blood samples and other samples with expected low IgM concentrations. Abbott has identified a solution to address this issue with a planned product modification expected in Q1 2017.

Device

Architect Toxo IgM Assay
  • Modèle / numéro de série
    Architect Toxo IgM AssayList Number: 6C20-25Lot Numbers: 64245LI00 (Exp.: 12/04/2017), 66063LI00 (Exp.: 13/05/2017), 67003LI00 (Exp.: 12/05/2017), 68443LI00 (Exp.: 19/07/2017)ARTG Number: 188821
  • 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