Events

Alerte De Sécurité sur ORTHO VISION Analyzer ORTHO VISION analyzer Technical name: General biochemistry, hormone, drug or protein analysis instrument ANVISA registration number: 80145901739 Hazard class: II Affected model: ORTHO VISION Analyzer Affected serial numbers: All SKU equipment 6904579, with software versions 3.6.0 and earlier

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ortho Clinical Diagnostics.

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
  • ID de l'événement
    2240
  • Date
    2017-03-20
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notes supplémentaires dans les données
    Some instructions are recommended: • After adjusting the incubation time parameters of a UDP test, the client must make sure to restart the system before processing the samples so that the incubation time parameters will be reset to the values ​​of the Assay Data Disk (ADD) for the Ortho test model and the associated UDPs will be reset to the original parameters validated during the analyzer reset. • Place this notification on your ORTHO VISION Analyzer or along with the user documentation. • Complete and return the Receipt Confirmation form
  • Cause
    Ortho clinical diagnostics (ortho) has confirmed that when the incubation time parameters are changed when creating a user defined protocol (udp) test, the incubation time may change to the ortho test and other udp created from the same test protocol. the system will update the incubation time according to the last selection for all udps using the same protocol and will also update the ortho test protocol.
  • Action
    Field Action Code TC2016-225 / 16000172 triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Company will make correction in the field.

Device

ORTHO VISION Analyzer ORTHO VISION analyzer Technical name: General biochemistry, hormone, drug o...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ortho Clinical Diagnostics