Events

Alerte De Sécurité sur Product name: VITROS 4600 CHEMICAL SYSTEM / VITROS 5600 INTEGRATED SYSTEM Technical Name: Biochemical Analyzer / Biochemical Analyzer ANVISA Registration Number: 80145901335 Hazard Class: I Affected Model: Vitros 4600 Chemical (Viton 4600 / 5600 (R.Anvisa 80145901205) Serial numbers affected: VITROS® 4600 Chemistry System, Software Version 3.3, Product Code 6802445. VITROS® 5600 Integrated System, Software Version 3.3, Product Code 6802413 and 6802915.

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
    2106
  • Date
    2016-10-18
  • 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
    • Ensure that previously downloaded V-Docs for Software Version 3.3 are replaced with the correct files when installing the software through the DVD. Correct V-Docs files are available on the software DVD being sent to all clients. Additional instructions and information are located on page three. • Continue to consult the attached Technical Bulletin until the correct V-Docs files for Software Version 3.3 are in the system (s). • Place this notification on the VITROS System or together with the user documentation. • Complete and return the Receipt Confirmation Form. Please enter the J number of the systems on which you installed the software through the DVD.
  • Cause
    This notice provides additional information from a product correction notification that ortho-clinical diagnostics, inc. (ortho) issued in december 2015 with the following sequence of events: • december 2015: ortho issued a notice of correction product (ref. cl2015-201) on the need to clarify the actions of the operator after receiving condition codes u90-382 generated by vitros systems. condition codes u90-382 are associated with wash error codes. • may 2016: ortho issued a follow-up notification (ref. cl2016-072) and technical bulletin with new operator actions recommended when receiving condition codes u90-382. • august 2016: ortho issued a notice (ref. cl2016-093) on the availability of software version 3.3. later, it was identified that software version 3.3 launched via e-connectivity® contained files of the v-docs associated to the previous version of the software (that is, version 3.2).
  • Action
    Field Action Code 16000153 triggered under the responsibility of Johnson & Johnson of Brazil Ind. And Com. De Prod. for Health Ltda. Company will make correction in the field.

Device

Product name: VITROS 4600 CHEMICAL SYSTEM / VITROS 5600 INTEGRATED SYSTEM Technical Name: Biochem...

Manufacturer

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