Events

Retiro De Equipo (Recall) de PHADIA 250 SYSTEM - INSTRUMENT REAGENTS

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
    24248
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-03-06
  • 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
    There have been reports of instrument malfunctions for phadia 250 due to deformed bottles in the below mentioned products and lots. the deformation of the bottle can cause an erroneous volume detection by the instrument which will result in insufficient aspiration of sample diluent thus generating insufficient dilution of patient samples. the deformation is described as a flange or brim located on the inside lower part of the vial opening. the instrument malfunction due to deformed bottles could cause erroneous test results mainly false positive with regard to all elia assays and mainly falsely increased test results for immunocap total ige and immunocap igg4/igg assays. the frequency of this bottle defect is very low and not every defective bottle will cause the error. an instrument malfunction caused by deformed bottles will generate the instrument error message "3-145 right arm liquid detection below lower limit with target 2". it is important that you review your records for the above mentioned error message.

Device

PHADIA 250 SYSTEM - INSTRUMENT REAGENTS
  • Modelo / Serial
    Model Catalog: 83-1023-01 (Lot serial: JM3Y); Model Catalog: 83-1023-01 (Lot serial: JS0B); Model Catalog: 83-1023-01 (Lot serial: JP87); Model Catalog: 83-1023-01 (Lot serial: JK5N); Model Catalog: 83-1023-01 (Lot serial: JU9C)
  • Descripción del producto
    EliA Sample Diluent
  • Manufacturer
    PHADIA AB

Manufacturer

PHADIA AB