Events

Alerte De Sécurité sur i-STAT PT/INR Cartridge

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 Point of Care Division.

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
    2013-11-04
  • Date de publication de l'événement
    2013-11-04
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131104b.html
  • 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 i-stat pt/inr cartridge the therapeutic goods administration (tga), australia issued a medical device safety alert concerning i-stat pt/inr cartridge, manufactured by abbott point of care division. the affected list number is 3p89-24, and the affected lot numbers are 1 c103139 to and including c13270a. abbott point of care has determined that the i-stat pt/inr cartridge lots have the potential to exhibit incorrectly elevated results. internal studies have demonstrated that i-stat pt/inr results are elevated by an average of approximately 10% as compared to the international reference preparation (rtf/09) in the therapeutic range of 1.8 to 3.0 inr. the manufacture advises users to destroy unused stock. any remaining stock will be replaced by abbott. also, the manufacturer advises that a review of previous results may be performed at the discretion of the laboratory manager. for details, please refer to tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-01119-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 4 november 2013.

Device

i-STAT PT/INR Cartridge
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Abbott i-STAT PT/INR Cartridge
  • Manufacturer
    Abbott Point of Care Division

Manufacturer

Abbott Point of Care 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
    DH