Alerte De Sécurité sur ARCHITECT STAT High Sensitive Troponin-I Assay

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Abbott.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
  • Date de publication de l'événement
  • Pays de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: abbott architect stat high sensitive troponin-i assay medical device manufacturer, abbott, has issued a medical device safety alert concerning its architect stat high sensitive troponin-i assay. the manufacturer is informing affected users of a product recall and reduced expiration dating for select architect stat high sensitive troponin-i reagent lots. predictive quality assurance monitoring of architect stat high sensitive troponin-i reagent lots was initiated following the field action that occurred in january (fa21jan2016). as a result, the manufacturer has identified a potential for increased calibration failures prior to the expiration date. according to the manufacturer, there is a potential for delay in results due to calibration errors and failure to calibrate. nonetheless, there is no impact to generated patient results. manufacturer will continue to monitor performance of all on-market lots. until root cause is determined and corrective actions are implemented, new reagent lots will have a proactively shortened expiration date of 4 months from date of manufacture. the expiration date will require adjustments to the laboratory inventory and order management practices. affected users are instructed either: to destroy any remaining inventory of affected lots once an alternate reagent lot is available, or to adjust the expiration date of the affected lots according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 3 may 2016.


  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Abbott ARCHITECT STAT High Sensitive Troponin-I Assay
  • Manufacturer


  • Société-mère du fabricant (2017)
  • 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