Events

Retiro De Equipo (Recall) de UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - OSTASE ASSAY

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BECKMAN COULTER CANADA L.P..

¿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
    62301
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-10-25
  • 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
    Beckman coulter has determined that specific access ostase calibrator and qc lots do not meet their expiration date claims within our 10% criteria. for these lots we determined that ref b83876 and b83877 have 68 days of stability and ref 37305 and 37309 have 51 days of stability. access ostase calibrator and qc instability could result in falsely elevated patient results or qc failures. for 37305/37309 the instability could cause patient results to be overestimated by as much as 16% at the original expiration dates. for b83876/b83877 the instability could cause patient results to be overestimated by as much as 16% as of october 17 2016.

Device

UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - OSTASE ASSAY
  • Modelo / Serial
    Model Catalog: 37309 (Lot serial: 628296); Model Catalog: 37309 (Lot serial: 628297); Model Catalog: 37305 (Lot serial: 628297); Model Catalog: 37305 (Lot serial: 628294); Model Catalog: 37305 (Lot serial: 628296); Model Catalog: 37309 (Lot serial: 628294); Model Catalog: B83877 (Lot serial: 626001); Model Catalog: B83877 (Lot serial: 623208); Model Catalog: B83876 (Lot serial: 623207); Model Catalog: B83876 (Lot serial: 626000)
  • Descripción del producto
    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - OSTASE ASSAY;ACCESS SYSTEM - OSTASE ASSAY;UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM - OSTASE ASSAY;ACCESS OSTASE QC;ACCESS OSTASE CALIBRATORS
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    HC