Events

Rappel de ARCHITECT STAT High Sensitive Troponin-I Reagent Kit. 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-00561-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-04-29
  • 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-00561-1
  • 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
    Predictive quality assurance monitoring of architect stat high sensitive troponin-i reagent lots was initiated following a field action on a single lot of architect stat high sensitive troponin-i reagent in january, which impacted only selected countries. as a result, abbott has identified a potential for increased calibration failures prior to the expiration date. there is no impact to generated patient results. there is a potential for delay in results due to calibration errors and failure to calibrate which may lead to delayed treatment of life threatening injury.
  • Action
    Abbott is advising users that for certain lots, affected products can be used provided the calibration passes. Alternative lots should be ordered as soon as possible, and if the calibration fails to use an alternative lot. Once an unaffected lot is available, any remaining affected lots should be discarded. For certain lots, the expiration date should be amended as instructed. The expiration date for these lots will need to be manually tracked, as the system will maintain the original expiry date. Abbott is advising users that all new stock will have the expiry dates lowered to 4 months until corrective actions can be implemented. This action has been closed-out on 28/02/2018.

Device

ARCHITECT STAT High Sensitive Troponin-I Reagent Kit. An in vitro diagnostic medical device (IVD)
  • Modèle / numéro de série
    ARCHITECT STAT High Sensitive Troponin-I Reagent Kit. An in vitro diagnostic medical device (IVD)100 Test KitList Numbers: 3P25-25, 3P25-26Multiple Lot Numbers affected500 Test KitList Numbers: 3P25-35, 3P25-36Multiple Lot Numbers affectedARTG Number: 208227
  • 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