Events

Retiro De Equipo (Recall) de VITROS CHEMISTRY PRODUCTS SYSTEM - CA SLIDES (CALCIUM)

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
    75785
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-05-24
  • 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 diagnostics (ortho) has initiated this recall due to a potential for negatively biased serum sample results to be generated when using vitros ca slides gen 29. ortho confirmed an average negative bias of -0.45 mg/dl (-0.11 mmol/l) within the serum reference interval (8.4 - 10.2 mg/dl or (2.10 - 2.55 mmol/l) when using vitros ca slides gen 29. plasma and serum samples are similarly affected as both sample types use the same calibration parameters (math) when results are produced. though unconfirmed to date ortho has no indication that urine sample results generated when using vitros ca slides gen 29 are affected. as a result customers are being instructed to discontinue the use of vitros ca slides gen 29.

Device

VITROS CHEMISTRY PRODUCTS SYSTEM - CA SLIDES (CALCIUM)
  • Modelo / Serial
    Model Catalog: 1450261 (Lot serial: 0329-0528-9265); Model Catalog: 1450261 (Lot serial: 0329-0528-9176); Model Catalog: 1450261 (Lot serial: 0329-0528-8902); Model Catalog: 1450261 (Lot serial: 0329-0528-6999); Model Catalog: 1450261 (Lot serial: 0329-0528-9167)
  • Descripción del producto
    VITROS Chemistry Products Calcium (Ca) Slides
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS