Events

Retiro De Equipo (Recall) de VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - HAPTOGLOBIN (HPT) ASSAY

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

¿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
    44723
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-11-05
  • 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
    Ortho clinical diagnostic (ocd) has received complaints of the inability to calibrate the vitros? chemistry products hpt reagent. ocd has also received reports of an increase in u91-274 condition codes. although all affected lots met all release testing specifications prior to distribution an ocd investigation has confirmed an increased occurrence of condition codes and calibration failures when using these lots over a period of time. ocd testing has found that as the reagent ages a potential for biased results exists if you are able to obtain a valid calibration.

Device

VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - HAPTOGLOBIN (HPT) ASSAY
  • Modelo / Serial
    Model Catalog: 680 2214 (Lot serial: 1533-20-2314); Model Catalog: 680 2214 (Lot serial: 1533-19-2133)
  • Descripción del producto
    VITROS Chemistry Products HPT Reagent
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS