Events

Retiro De Equipo (Recall) de QUALICHECK 3

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por RADIOMETER MEDICAL APS.

¿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
    28157
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-03-21
  • 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
    Radiometer has recently become aware that supplementary inserts for some lots of s7335 (autocheck 3+ level 1) distributed in connection with the release of sofware version 6.16 for the abl800 series analyzers state an incorrect control range for pco2 in "abl810/820/830 sw more than v6.16" column. on the incorrect inserts both the low and high limits are offset by +1.3 mmhg for all affected lots. this also applies to the value in the barcode in the insert. the bar code is used to upload the values to the analyzer.

Device

QUALICHECK 3
  • Modelo / Serial
    Model Catalog: S7335 (Lot serial: 0335); Model Catalog: S7335 (Lot serial: 0304); Model Catalog: S7335 (Lot serial: 0333); Model Catalog: S7335 (Lot serial: 0332); Model Catalog: S7335 (Lot serial: 0331); Model Catalog: S7335 (Lot serial: 0330); Model Catalog: S7335 (Lot serial: 0329); Model Catalog: S7335 (Lot serial: 0328); Model Catalog: S7335 (Lot serial: 0327); Model Catalog: S7335 (Lot serial: 0326); Model Catalog: S7335 (Lot serial: 0325); Model Catalog: S7335 (Lot serial: 0324); Model Catalog: S7335 (Lot serial: 0323); Model Catalog: S7335 (Lot serial: 0322); Model Catalog: S7335 (Lot serial: 0321); Model Catalog: S7335 (Lot serial: 0305); Model Catalog: S7335 (Lot serial: 0334)
  • Descripción del producto
    QUALICHECK 3
  • Manufacturer
    RADIOMETER MEDICAL APS

Manufacturer

RADIOMETER MEDICAL APS