Events

Retiro De Equipo (Recall) de VITROS 5600 INTEGRATED SYSTEM - INSTRUMENT

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
    91139
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2014-04-14
  • 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
    Ocd has issued a recall due to the potential for biased results when a multiple window (mw) code is associated with results generated by the vitros 5600 integrated system vitros 4600 chemistry system and vitros 51 chemistry system. mw codes may be associated with results from any of the following vitros chemistry products using multiple point (multipoint) rate measurements: alt slides alkp slides ast slides che slides ck slides ggt slides ldh slides. multipoint rate assays measure enzyme activity via multiple readings which are used to generate a kinetic curve and calculate results. the mw algorithm assesses the validity of the kinetic curve. an mw code is generated if a single point exceeds predetermined limits provided that all surrounding values are within acceptable limits.

Device

VITROS 5600 INTEGRATED SYSTEM - INSTRUMENT
  • Modelo / Serial
    Model Catalog: 680 2413 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 6801375 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 680 2445 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 6801890 (Lot serial: > 10 numbers contact mfg.)
  • Descripción del producto
    VITROS 5600 INTEGRATED SYSTEM - INSTRUMENT
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS