Events

Alerta De Seguridad para Automatic Range Counter Wizard2, Model 2470 and 2480 Registration 10298910126, I-lot class: SGWZ13130003, SGWZ21330009, SGWZ42130052, SGWZ50130087, SGWZ14140125, SGWZ18140139, DG10129753, DG01130080, DG12120010, DG04130302, SGWZ20140148, SGWZ34140184, and SGWZ42140202.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por PerkinElmer do Brasil Ltda.; PerkinElmer Singapore Pte 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
    1644
  • Fecha
    2015-07-22
  • 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 the health impact is dependent on the clinical application in which the Gama Wizard² counter is being used. The applications are: gamma count measurement, radioimmunoassay tests, determination of glomerular filtration rates and dose determination of radiopharmaceuticals in nuclear medicine.
  • Causa
    Error in the contents of the second bar code of label no. 23. the label is being incorrectly identified as #. 24 when scanned.
  • Acción
    The company that holds the registration guides the immediate destruction of all barcode labels. 23 that are in the possession of the clients. The Wizard2 Gamma Counter contains a total of 20 bar code labels identified as # 23 (ie, 02 labels on each of the 10 pages). Be sure to inspect all sample racks to remove and destroy all # 23 bar code labels already attached to the racks.

Device

Automatic Range Counter Wizard2, Model 2470 and 2480 Registration 10298910126, I-lot class: SGWZ1...

Manufacturer

PerkinElmer do Brasil Ltda.; PerkinElmer Singapore Pte Ltd.