Events

Alerte De Sécurité sur Ortho Vision Analyzer Technical Name: Immunohematology Equipment ANVISA Registration Number: 80145901739 Hazard Class: I Affected Model: Ortho Vision Analyzer Affected Series Numbers: ORTHO VISION® Cassette Analyzer ORTHO BioVue®, Product Code 6904579, Version of software 3.6.0 and earlier, Serial number 60002256 and 60002257.

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, 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
  • ID de l'événement
    2115
  • Date
    2016-12-21
  • 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
    • Load and discharge only the samples, reagent or diluent using the wizard shown on the Samples or Reagents screen, according to the instructions in the ORTHO VISION Reference Guide. • After making a Load / Unload request, make changes only to the position of LOAD STATION, whose access was specifically requested in the GUI interface. • Place this notification on the ORTHO VISION Analyzer or together with the user documentation. • Complete and return the Receipt Confirmation form.
  • Cause
    In february and march 2016, ortho clinical diagnostics (ortho) issued an urgent notice of product correction to an improbable scenario, in which after making a reagent loading / discharging request, a user removes or swaps samples into a rack, removes or exchanges diluents, or removes a dilution rack from a location that has not been selected in the "graphical user interface (gui)" interface. note: brazil was not affected in the initial communication (february and march 2016). ortho is issuing this update for urgent product correction notifications because, after issuing the notifications, ortho has identified that a normal process deviation, when accessing any location in the loading station area (samples, reagents or diluents) does not specified in the interface (gui), may not be detected by the parser. the system does not re-scan the barcodes of the positions exposed to the user in any area of ​​the load station, different from the location requested in the gui interface.
  • Action
    Field Action Code 16000170 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 Technical Name: Immunohematology Equipment ANVISA Registration Number: 8014...

Manufacturer

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