Events

Retiro De Equipo (Recall) de PHADIA 100 SYSTEM - ALLERGENS

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por PHADIA AB.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    66405
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2018-01-02
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Somagen diagnostics along with thermofisher scientific would like to notify you of an urgent recall and backorder of immunocap allergen c5 ampicilloyl product code 14-4450-01 and immunocap allergen c6 amoxicilloyl product code 14-4451-01. an internal monitoring stability study has indicated that stability specifications have not been met and were in fact half the intended expiry date of 12 months. there is a possibility that samples with a low positive concentration may be incorrectly reported as negative. any reported test results below the assay limit of qualification (loq) should be disregarded as these results may be invalid. no complaints or injuries to patients have been reported.

Device

PHADIA 100 SYSTEM - ALLERGENS
  • Modelo / Serial
    Model Catalog: 14-4451-01 (Lot serial: 991D7); Model Catalog: 14-4451-01 (Lot serial: 991DC); Model Catalog: 14-4451-01 (Lot serial: 991DB); Model Catalog: 14-4451-01 (Lot serial: 991D8); Model Catalog: 14-4451-01 (Lot serial: 991D9); Model Catalog: 14-4450-01 (Lot serial: 990DT); Model Catalog: 14-4450-01 (Lot serial: 990DS); Model Catalog: 14-4450-01 (Lot serial: 990DU); Model Catalog: 14-4450-01 (Lot serial: 990DV); Model Catalog: 14-4451-01 (Lot serial: 991DA); Model Catalog: 14-4450-01 (Lot serial: 990DX); Model Catalog: 14-4450-01 (Lot serial: 990DY); Model Catalog: 14-4450-01 (Lot serial: 990DZ); Model Catalog: 14-4450-01 (Lot serial: 990DW)
  • Descripción del producto
    ImmunoCAP Allergen c6 Amoxicilloyl;ImmunoCAP Allergen c5 Ampicilloyl
  • Manufacturer
    PHADIA AB

Manufacturer

PHADIA AB