Events

Rappel de ARCHITECT DHEA-S Reagents. 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-2017-RN-01526-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-12-18
  • 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-01526-1
  • 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 has identified that falsely elevated results may be obtained when using the architect dhea-s assay with samples from infants up to 60 days old. the specific cause of the elevated results is currently under investigation. although falsely elevated results have only been observed with samples from infants up to 60 days old, the expected values representative data for children up to 10 years old provided in the architect dhea-s reagent insert should not be used as these reference ranges are being reviewed as part of the investigation.All in-date lots of current reagent inventory are impacted.
  • Action
    Abbot is advising users to immediately discontinue use of the ARCHITECT DHEA-S assay with samples from infants up to 60 days old and to immediately discontinue use of the ARCHITECT DHEA-S reagent insert Expected Values representative data for children up to 10 years old. Users are advised to review this letter with the Medical Director and follow laboratory protocol regarding the need for reviewing previously reported patient results.

Device

ARCHITECT DHEA-S Reagents. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    ARCHITECT DHEA-S Reagents. An in vitro diagnostic medical device (IVD)List Number: 8K27-20 Lot Numbers: 01316K000, 01217A000, 02217D000, 04117H000List Number: 8K27-25Lot Numbers: 01216K000, 01117A000, 02417D000, 00517F000ARTG Number: 196075
  • 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