Events

Alerta De Seguridad para Placental growth factor - Delfia Xpress PIGF kit, record 10298910109, hazard class II, lots 637790

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
    1645
  • 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 instructions for use the results should only be reported if the values ​​are within the range defined as acceptable. That is, incorrect results should not be reported to patients. The associated risk is due to delays in the screening of patients for pre-eclampsia and Down's syndrome in the first trimester.
  • Causa
    Problem related to the stability of lot 637341 of pigf calibrators of the delphia pigf kits (6007-0010, 6007-000 and 6007-002c). the problem is limited to a batch of the pigf calibrators, which is included in the described pigf kit lots. due to the stability problem, there is a tendency to decrease the signal level measured in the calibrators to 20%.
  • Acción
    The company that holds the registration guides the immediate discontinuation in the use of the DELFIA Xpress PIGF kit lots highlighted in this field action. The kits should be destroyed. It is requested the analysis of the PIGF control values ​​for the enumerated lots, complete verification. In case QC controls are within acceptable range, the results of samples should be considered valid. If there are deviations, it is recommended to repeat the samples with another kit lot. The kits will be replaced by the manufacturer.

Device

Placental growth factor - Delfia Xpress PIGF kit, record 10298910109, hazard class II, lots 637790

Manufacturer

PerkinElmer do Brasil Ltda.; Wallac Ou