Events

Alerte De Sécurité sur IH-1000

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

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
    2013-06-17
  • Date de publication de l'événement
    2013-06-17
  • 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_20130617.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: bio-rad ih-1000 the australia therapeutic goods administration (tga) has posted a medical device safety alert concerning ih-1000, manufactured by bio-rad. the affected product reference number is 001000 and all software versions are affected. in some specific conditions, inconsistent grading between the results in the well/card and the results returned by the ih-1000 may be observed. in these very specific conditions, positive reactions might be read as negative by the system due to the analysis algorithm of the images. therefore, this issue might lead to a wrong result released to the host if the 3 following conditions are met: a result is returned as negative while the reaction is positive, double population, or requires a human interpretation and, this negative result is consistent with the global interpretation of the test and, the system is configured without the second reading function activated for all tests results. the manufacturer is providing work around instructions as an interim measure. a software update will be implemented to permanently correct the issue. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00593-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 june 2013.

Device

IH-1000
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Bio-Rad IH-1000
  • Manufacturer
    Bio-Rad

Manufacturer

Bio-Rad