Events

Alerta De Seguridad para GSP Genetic Screening Processor Technical Name: ANVISA Registration Number: 10298910108 Hazard Class: I Affected Model: 2021-0010 Affected serial numbers: 20210154, 20210207, 20210171, 20210163, 20210161, 20210208.

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.; Wallac Ou.

¿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
    2193
  • Fecha
    2016-09-02
  • 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
    Defective insulation will be replaced during the next scheduled periodic maintenance visit or service visit. The visit can also be scheduled if requested by the client.
  • Causa
    We are aware that the insulation of the heated incubator door is defective in the instrument serial numbers listed above due to a change in the insulation production method. the film may come loose from the outer surface of the insulation, causing a mechanical motion error or a temperature control error. due to the defect, the instrument's operations will stop and it will require repair by perkinelmer field service engineers. instrument performance is only affected when error occurs in mechanical movement or temperature control. the operation of the heated incubator is involved during the incubation steps of the gsp neonatal galt (3303-0010 and 3303-001u) and gsp neonatal biotinidase (3307-0010, 3307-001u) assays which require a high temperature (+ 37 ° c ). the functionality of the heated incubator door is also checked during the instrument start procedure.
  • Acción
    Field Action Code 2016.06.005461 triggered under the responsibility of the company PerkinElmer do Brasil Ltda. Company will make correction in the field.

Device

GSP Genetic Screening Processor Technical Name: ANVISA Registration Number: 10298910108 Hazard Cl...

Manufacturer

PerkinElmer do Brasil Ltda.; Wallac Ou