Events

Alerta De Seguridad para KIT DIAGNOSTIC PEPTIDE C - IMMULITE 2000 / SIEMENS .. LOT: 105L .. REGISTER NUMBER: 10071770336

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS - EURO DPC; DPC MEDLAB PRODUTOS MÉDICO HOSPITALARES 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
    898
  • Fecha
    2008-01-11
  • 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
    Anvisa's Technovigilance Unit has already requested more information from DPC Medlab Ltda and is awaiting response from it. #### Update (27/02/2008): The UTVIG / NUVIG is monitoring this case.
  • Causa
    The manufacturer's quality control department (siemens medical solutions diagnostics) has identified that lot 105l of the immulite 2000 c peptide diagnostic kit product tends to present adjustment curves with a higher adjustment coefficient than is normally observed, accompanied by a higher tendency to show greater deviations.
  • Acción
    The manufacturer company is voluntarily collecting the batch under suspicion of the product at international level. In Brazil, the company that owns the product registration (DPC MEDLAB PRODUCTOS MÉDICO HOSPITALARES LTDA) has already been contacted by the Anvisa Tecnovigilance Unit to supplement information regarding the collection. #### Update (27/02/2008): The company DPC MEDLAB LTDA sent to UTVIG / ANVISA a copy of the communication letter sent to its customers, informing that the aforementioned product should be discarded immediately.

Device

KIT DIAGNOSTIC PEPTIDE C - IMMULITE 2000 / SIEMENS .. LOT: 105L .. REGISTER NUMBER: 10071770336

Manufacturer

SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS - EURO DPC; DPC MEDLAB PRODUTOS MÉDICO HOSPITALARES LTDA
  • Source
    ANVSANVISA