Events

Alerta De Seguridad para ANTIGEN AND ANTIBODY FOR HEPATITIS C VIRUSES (HCV AG / ANTI-HCV) ANVISA registration number: 80020690319 Hazard class: IV Affected model: 480 tests / 96 tests Numbers of series affected: 6J0533, 6K0535, 6M0536 and 6K0534

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Bio-Rad Laboratórios Brasil Ltda; Bio-Rad.

¿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
    2296
  • Fecha
    2017-05-19
  • 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 a result of this notification, we ask users to: • Continue to use affected kits and batches as long as the validation criteria are met (refer to the product use instruction (section 7.5) for detailed instructions): 1) For negative control R3 : OF 0.500 • Stop using batches affected if validation criteria fail.
  • Causa
    Decrease of all optical density (od) values ​​for samples and controls tested. this may result in board invalidation. the phenomenon that causes an overall decrease of all od values ​​appears a few months after the batch release. positive control of recombinant antigen - r5 (synthetic base peptide) is more affected by the decrease in od values ​​and results in invalidation of the run when its od becomes lower than 0.5. however, since the final results (reasons) are not impacted, there is no risk of incorrect result. reagent r6 (conjugate 1 - biotinylated monoclonal antibodies against hcv capsid antigen) was identified as the main cause of this decrease in od values.
  • Acción
    Field Action Code Bio-Rad_AC-001/2017 triggered under the responsibility of Bio-Rad Laboratorios Brasil Ltda. Company will send a statement.

Device

ANTIGEN AND ANTIBODY FOR HEPATITIS C VIRUSES (HCV AG / ANTI-HCV) ANVISA registration number: 8002...

Manufacturer

Bio-Rad Laboratórios Brasil Ltda; Bio-Rad