Events

Alerte De Sécurité sur vitros 3600 immunodiagnostics system and vitros 5600 integrated system, software version 3.2.2 and below

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

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
    2016-04-14
  • Date de publication de l'événement
    2016-04-14
  • 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_20160414.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: ortho-clinical vitros 3600 immunodiagnostics system and vitros 5600 integrated system, software version 3.2.2 and below the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning vitros 3600 immunodiagnostics system and vitros 5600 integrated system, software version 3.2.2 and below, manufactured by ortho-clinical diagnostics inc. product code: 6802783 and 6802413 unique device id: 10758750002979 and10758750002740 according to the manufacturer, a vitros system software timing anomaly has been identified that could cause two different sample metering scenarios that may lead to erroneous results: scenario 1: the vitros system could aspirate sample from an unintended sample container causing assay result(s) obtained from that sample to be incorrectly associated with the intended sample. scenario 2: a sample could be aspirated from a sample container (sample a) and be dispensed into an unintended container (sample b) to be contaminated and diluted by sample a. there is the potential for false negative and false positive results which may lead to an inappropriate diagnosis and patient management leading to serious patient injury. the manufacturer is providing users with interim instructions to follow to decrease the probability of the issues occurring, and can review the affected systems to determine if the errors have occurred. besides, the manufacturer is providing users with a software update (and associated modification modules) as a permanent correction. for details, please refer to the tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2016-rn-00420-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 14 april 2016.

Device

vitros 3600 immunodiagnostics system and vitros 5600 integrated system, software version 3.2.2 an...
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Ortho-clinical VITROS 3600 Immunodiagnostics System and VITROS 5600 Integrated System, software version 3.2.2 and below
  • Manufacturer
    Ortho-clinical Diagnostics Inc

Manufacturer

Ortho-clinical Diagnostics Inc