Events

Alerta De Seguridad para VITROS IMMUNODIAGNOSIS CALIBRATOR * FOR CA 19-9, registration 10132590514 and VITROS IMUNODIAGNOSTIC REAGENT KIT * FOR CA 19-9, registration 10132590488 - 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
    1413
  • Fecha
    2014-07-28
  • 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
    As assessed by the manufacturer, this is a situation in which the use of or exposure to the affected product may lead to temporary or clinically reversible adverse health effects, or where the likelihood of serious adverse health consequences is remote.
  • Causa
    The company holding the registration informs that the product vitros® ca 19-9 reagent packs are used in vitros® eci / eciq immunodynamic systems, vitros® 3600 immunodiagnostic systems and vitros® 5600 integrated systems for the quantitative measurement of the defined antigen 1116-ns -19-9 in human serum and plasma. internal tests confirmed positive bias results generated with vitros® ca19-9, lot 1320. results from patient samples and proficiency samples showed positive bias in lot 1320 compared to previous batches.
  • Acción
    The company directs customers to: i- Discontinue use immediately and discard all remaining inventory of CA19-9 Calibrators and Reagent Packs, Lot 1320, ii- Review previously reported results with VITROS® CA 19-9 Reagent Packs, Lot 1320, iii - Discuss with the Medical Director of the Laboratory or the requesting physician any questions you may have regarding previously reported results to determine the appropriate course of action. More information in the Letter to the Client - Annex II

Device

VITROS IMMUNODIAGNOSIS CALIBRATOR * FOR CA 19-9, registration 10132590514 and VITROS IMUNODIAGNOS...

Manufacturer

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