Events

Alerte De Sécurité sur Modular Analyzers of Clinical Chemistry based on Immunological Assays: (1) Model E170, (2) Integrated Model E170. Catalog No.: 7656961, 7657009, 7657021, 7657900; all serial numbers.

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 Roche Diagnostics Corp [391899], 9115 Hague Rd, Indianapolis IN 46256 (distribuidor); Hitachi Ltd Ibaraki-Ken 312-8504, Japan (fabricante).

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
    692
  • Date
    2003-03-07
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    Liquid may leak from the above mentioned analyzers, which may cause smoke) and / or damage to the units. the distributor notified by letter dated 18 october 2002.
  • Action
    Make sure you received the Roche letter on October 18, 2002. Identify any affected product in your inventory. Until assembly / adjustment is complete, if you see or smell smoke, immediately turn off the system at the main switch, and call the Roche Technical Support Center. For additional information, schedule a technical visit in your area, and to arrange the units in your inventory, contact your local Roche representative. ANVISA has provided the Occurrence Notification Forms on the Internet http://www.anvisa.gov.br/sistec/notificacaoavulsa/notificacaoavulsa1.asp so that you notify if there are any problems with the products in your inventory. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

Modular Analyzers of Clinical Chemistry based on Immunological Assays: (1) Model E170, (2) Integr...

Manufacturer

Roche Diagnostics Corp [391899], 9115 Hague Rd, Indianapolis IN 46256 (distribuidor); Hitachi Ltd...
  • Source
    ANVSANVISA