Events

Alerta De Seguridad para Dako complementary reagents, for the following products: 1. Envision FLEX mini-kit, High pH (Link), Registration: 80640680042, lot 20021362 //// 2. Envision FLEX, Hig pH (link), K8023 registration 80640680042, lot 20020777; 20019097; 20021381 //// 3. EnVision FLEX min-kit, High pH (Autostainer / Autostainer Plus), K8010, registration 80640680034, lot 20020792; 20021384. //// 4. EnVision FLEX + Mouse, High pH (link); K8002; registration 80640680042, lot 20019113; 20020772. //// 5. EnVision Flex + Mouse, mini-kit, High pH (Autostainer / AUtostainer Plus), K8012, registration 80640680034. All risk class I.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Olympus Optical do Brasil Ltda.; Olympus Medical Systems Corporation..

¿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
    1731
  • Fecha
    2015-10-31
  • 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, nonspecific staining can be confused with specific reaction and lead to false positive result. There was no evidence of risk to patients. It is highly unlikely that a diagnostic error occurred if: a suitable negative control tissue had been included in the auxiliary test and not as the sole basis for the diagnosis or treatment regimen.
  • Causa
    A defect was identified in the buffer composing the formulation of one of the kit components, in particular, the polymer / hrp. specific non-specific or specific staining was observed when this reagent was used with four antibodies: epstein-barr virus, mum-1 protein, wilm's tumor (wt-1), smooth muscle actin. there is a possibility that nonspecific staining may be confused by a specific reaction, leading to a false positive result.
  • Acción
    The company that holds the record will destroy the target products of the field action. It recommended that cases submitted to affected lots be reassessed. Action code: CAPA00544

Device

Dako complementary reagents, for the following products: 1. Envision FLEX mini-kit, High pH (Link...

Manufacturer

Olympus Optical do Brasil Ltda.; Olympus Medical Systems Corporation.