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
    120285
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-02-15
  • 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
    Immunocap allergen fx20 food contains a mix of f4 (wheat) f5 (rye) f6 (barley) f9 (rice). due to a production nonconformity the above mentioned lots of immunocap allergen fx20 food contain traces of oat (f7) allergen. the described nonconformity could cause false positive test results with regard to sensitization to fx20 allergens for samples that are positive for oat allergen and negative for wheat rye barley and rice allergens. however this is an unlikely event because of the extensive cross-reactivity between different cereal allergens and the low probability of monosensitization to oat allergen in patients. therefore it is unlikely that presence of oat allergen in immunocap allergen fx20 should result in incorrect test results for patient samples.

Device

PHADIA 100 SYSTEM - ALLERGENS
  • Modelo / Serial
    Model Catalog: 14-4853-01 (Lot serial: AAS0G); Model Catalog: 14-4853-01 (Lot serial: AAS0D); Model Catalog: 14-4853-01 (Lot serial: AAS0E); Model Catalog: 14-4853-01 (Lot serial: AASG3); Model Catalog: 14-4853-01 (Lot serial: AASG2); Model Catalog: 14-4853-01 (Lot serial: AASG1); Model Catalog: 14-4853-01 (Lot serial: AAS0H); Model Catalog: 14-4853-01 (Lot serial: AAS0F)
  • Descripción del producto
    IMMUNOCAP ALLERGEN FX20
  • Manufacturer
    PHADIA AB

Manufacturer

PHADIA AB