Events

Alerta De Seguridad para THERMO LABSYSTEMS. MODEL 65500, (6) MODEL 65400, (6) MODEL 65500, (6) MODEL 65500, (6). PHOTOMETRIC, MICROPLATE READING. ANALYZERS, LABORATORY, IMMUNOASSAY, PHOTOMETRIC, MICROPLATE READING

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por THERMO LABSYSTEMS OY (US) A THERMO ELECTRON CO; DYNEX TECHNOLOGIES INC SUB THERMO BIOANALYSIS CORP.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    64
  • Fecha
    2001-05-23
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    An incorrect sample volume may be released, taking a wrong result of the test in the analyzers mentioned. in addition, an electromagnetic incompatibility can make that the above analyzers report an error and travem. the manufacturer started a recall through correspondence sent on april 18, 2001.
  • Acción
    MAKE SURE YOU HAVE RECEIVED THE CORRESPONDENCE OF APRIL 18, 2001, SUBMITTED BY THERMO LABSYSTEMS OR DYNEX TECHNOLOGIES. IDENTIFY AND ISOLATE THE AFFECTED SYSTEM IN YOUR STOCK. FOR FURTHER INFORMATION, CONTACT THERMO LABSYSTEMS BY TEL. (800) 522-7763 WITHIN THE US OR BY TEL. (508) 541-0439 OUTSIDE THE USA.

Device

THERMO LABSYSTEMS. MODEL 65500, (6) MODEL 65400, (6) MODEL 65500, (6) MODEL 65500, (6). PHOTOMETR...

Manufacturer

THERMO LABSYSTEMS OY (US) A THERMO ELECTRON CO; DYNEX TECHNOLOGIES INC SUB THERMO BIOANALYSIS CORP
  • Source
    ANVSANVISA