Events

Alerta De Seguridad para CALIBRATION MODULE (CDM PROM) VITROS® NH3 DT Slides, GEN 59 - Code 1532589 - Registration 80145900916 - lots See Annex 1 - Distribution List

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ortho-Clinical Diagnostics.

¿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
    1672
  • Fecha
    2015-08-27
  • 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
    The manufacturer reinforces the inability to calibrate or use the VITROS® NH3 DT Slides, GEN 59 with the VITROS® DT Calibrator Kit, Lot 44, when the CDM PROM 0168 or 0169 is installed. During use, the operator will be required to operate bottles 1, 2, 4, and 4 instead of bottles 1, 2, 3, and 4. The customer will not be able to enter the information necessary to calibrate the assay.
  • Causa
    The registrant informs that product corrective action has been initiated due to the inability to calibrate or use vitros® nh3 dt slides, gen 59 with vitros® chemistry products dt calibrator kit, lot 44, when cdm prom 0168 or 0169 is installed on the vitros® dt60 / dt60 ii systems.
  • Acción
    • If you have the VITROS® DT Calibrator Kit, Lot 42, you can calibrate your current inventory of VITROS® NH3 DT Slides, GEN • If you have the VITROS® DT Calibrator Kit, Lot 42, you can calibrate your current inventory of VITROS® NH3 DT Slides, GEN 59 with CDM PROMs 0168 or 0169. • If the installation uses the VITROS® NH3 DT Slides and you need the CDM PROM 0170 to calibrate, enter in the Receipt Confirmation form the number of CDM PROMs that your installation needs. Further information - Annex 2 - Customer communication

Device

CALIBRATION MODULE (CDM PROM) VITROS® NH3 DT Slides, GEN 59 - Code 1532589 - Registration 8014590...

Manufacturer

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