Events

Alerta De Seguridad para Commercial Name: Reactive Dry Vitros for ProteinC Reactive CRP / Dry Reactive Vitros for ProteinC Reactive CRP Technical Name: C Reactive Protein / Protein C Reagent ANVISA Registration Number: 10132590348 Hazard Class: II Affected Model: Box with 5 cartridges x 50 slides / Box with 5 cartridges x 18 slides Serial Numbers Affected: VITROS Chemistry Products PCR Slides; Product Codes: 1926740 and 8097990. Considering the scope of the affected lots (already distributed and possible commercialization), the list of customers using the inputs affected by this field action was considered based on the equipment purchased.

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
    2112
  • Fecha
    2016-11-28
  • 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
    Follow the instructions in the alert letter to perform dilutions when processing samples above the PCR measurement range. VITROS PCR Slides Instructions for Use (IFUs) will be revised to include additional instructions to follow when diluting samples with results above the measurement range. Meanwhile, keep the notification as verification of the reviewed process for processing samples above the measurement range.
  • Causa
    Ortho clinical diagnostics (ortho) received pcr reports with positive deviation when using vitros pcr slides for sample dilution. vitros chemistry products pcr slides products quantitatively measure c-reactive protein (crp) concentration in serum and plasma using the vitros 250/350 / 5.1 fs and 4600 systems and the vitros 5600 integrated system.
  • Acción
    Field Action Code 16000165 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

Commercial Name: Reactive Dry Vitros for ProteinC Reactive CRP / Dry Reactive Vitros for ProteinC...

Manufacturer

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