Events

Rappel de Abbott RealTime HIV-1 Assay. 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 Molecular 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-2017-RN-01057-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-08-15
  • 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-2017-RN-01057-1
  • 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 molecular has identified that a specific lot of abbott realtime hiv-1 assay may exhibit a higher than expected rate of error codes. for plasma samples, this has the potential to exhibit false “not detected” results for hiv samples less than 120 copies/ml when using 0.6 ml assay application. for dried blood spot (dbs) samples when using a 1-spot protocol associated with the realtime hiv-1 package insert 51-608282, these are performing in accordance with the detection rate within the realtime hiv-1 package insert for dbs sample types.
  • Action
    Abbot is requesting users: 1. Review the supplied Abbott Molecular letter carefully and follow the instructions; 2. Complete and return the supplied Customer Reply Form; 3. Contact Abbott Customer Service for assistance if needed. If customers have forwarded the affected product to other laboratories, inform them of this Product Recall and provide to them a copy of the customer letter; and 4. Retain this letter for your laboratory records.

Device

Abbott RealTime HIV-1 Assay. An in vitro diagnostic medical device (IVD)

Manufacturer

Abbott Australasia Pty Ltd Molecular 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