Events

Alerta De Seguridad para Product Name: PSA Third Generation IMMULITE / IMMULITE 1000 Technical Name: SPECIFIC PROSTATE ANTIGEN (PSA) ANVISA Registration Number: 10345160987 Hazard Class: III Affected Model: 100 Test Kit / 500 Test Kit Serial Numbers Affected: 336; 337 and 338

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare Diagnostics Products Ltd..

¿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
    2072
  • Fecha
    2017-01-12
  • 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
    Siemens recommends the discontinuation and discontinuation of the mentioned lots and subsequent replacement request. The company does not recommend a review of previously generated results. ### UPDATED ON 10/26/2017, the company presented the completion report of the field action proving the sending of the security warning to the client with evidence of science and all actions completed.
  • Causa
    Siemens identified negative bias for batches 0336 and 0337 of the 3rd generation immulite psa (prostate specific antigen) assay. research by siemens has confirmed that patient samples may display a negative mean bias of approximately -22% with a range of -16% to -27% for samples ranging from 0.08 to 16.2 ng / ml. quality controls demonstrate a negative bias similar to those found in patient outcomes. depending on the quality control ranges used in your lab, this problem may not be identified by your qa material. a preliminary investigation at siemens indicates that the root cause of the negative bias is related to the adjusters used in kit lots 0336 and 0337. however, siemens has not yet confirmed a negative bias in kit lot 0338 until now, this lot is being included in this notice because this kit has the same batches of adjusters from lot kits 0336 and 0337. subsequently, 3rd generation immulite / immulite 1000 psa batches that do not have impacted lot adjusters in the kit will not be affected.
  • Acción
    Field Action BMI Code 17-05 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will notify the client.

Device

Product Name: PSA Third Generation IMMULITE / IMMULITE 1000 Technical Name: SPECIFIC PROSTATE ANT...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare Diagnostics Products Ltd.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA