Events

Alerta De Seguridad para IMUNO-LATEX PCR # Technical name: C REATIVE PROTEIN # COD. 2960-L; 29100-L # Register: 10310030072 # Risk Class: II - Products presenting medium risk to user or patient and low risk to public health # Kit for 60 or 100 tests # Presentation: Latex Suspension: Suspension of latex coated with antibody monoclonal anti-PCR stabilized in glycine buffer Positive Control Serum: Human serum in saline buffer and sodium azide Control Negative Serum: Human serum in saline buffer and sodium azide Control Serum Negative: Human serum in saline buffer and sodium azide

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por WAMA PRODUTOS PARA LABORATORIO LTDA.

¿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
    1405
  • Fecha
    2014-07-04
  • 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
    According to the company, "a false reactive PCR result would lead to a misdiagnosis that the patient has anti-PCR antibodies, but as described in the instructions for use, the kit is a test aid in the diagnosis of nonspecific inflammation with rapid onset (1 - 2 weeks) Positive results should always be confirmed by other diagnostic and clinical methods of the patient Another situation presented is agglutination of the reagent even before mixing with the patient sample, making it impossible to determine a Therefore, there are no health risks, since positive results must be complemented and the reagent will often present agglutination even before mixing with the sample, making it impossible for the laboratory to perform the test procedure.
  • Causa
    According to the company, "an increase in the rate of reactive pcr results has been identified (false positive), often the product is agglutinating (positive) even without the presence of the patient sample.".
  • Acción
    Company is making collection of affected lots for destruction. # AFFECTED LOTS: 14C017; 14C109; 14C111 # Attached: 1.Carta to Customers; 2. Distribution Map

Device

IMUNO-LATEX PCR # Technical name: C REATIVE PROTEIN # COD. 2960-L; 29100-L # Register: 1031003007...

Manufacturer

WAMA PRODUTOS PARA LABORATORIO LTDA