Events

Alerta De Seguridad para Name of reagent: Red cell Reag family for Immunohematology R4 - IH Biovue - Other items in Annex 1 Technical name: Reag for immunohematology - Red cell reagent / enzyme-treated red cell number ANVISA registration number: 80145901444 Hazard class: : Surgiscreen -Conj of 3 vials with 3mL each of cel for detection of unexpected antibodies Serial numbers affected: 3SS214Z; 3SS216Z; 3SS222Z; 3SS225Z; 3SS231Z; 3SS238Z; 3SS241Z; 8EA329; 8RA330; 8RA331; 8SS282; 8SS284; 8SS285; 8SS286; 8SS271; 8SS272; 8SS273; 8SS274; 8SS275; 8SS276; 8SS277; 8SS278; 8SS279; 8SS280; 8SS281; 8RC306; 8RC307; 8RC308; 8S893; 8S894; 8S896; 8ª511; 8ª512; 8ª222; 8ª523; 8,548; 8ª534.

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 Inc..

¿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
    2114
  • Fecha
    2016-12-02
  • 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
    • Visually inspect all products before use according to the Instructions for Use. Do not use red cell products if marked haemolysis or evidence of contamination is observed. • Contact the Ortho Care ™ Technical Solutions Center to report a product in which marked haemolysis has been observed so that the product can be replaced or credited. • Complete and return the Receipt Confirmation form.
  • Causa
    Ortho clinical diagnostics received a large number of customer complaints and confirmed the intermittent presence of marked hemolysis in ortho reagent red blood cell (rrbc) products, as well as quality control products containing red blood cells. ortho conducted extensive research and the root cause for marked haemolysis was identified as microbial contamination.
  • Acción
    Field Action Code 16000162 triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Company will make correction in the field.

Device

Name of reagent: Red cell Reag family for Immunohematology R4 - IH Biovue - Other items in Annex ...

Manufacturer

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