Events

Retiro De Equipo (Recall) de WATERS MASS SPECTROMETER - ACQUITY TQD IVD

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

¿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
    30897
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-10-17
  • 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
    There is a possibility that the ion block source heater may fail. in some instances the failure could cause a short term loss of or variation in sensitivity that may subsequently lead to inaccurate data. the loss of or variation in sensitivity is most pronounced in assays with shorter dwell times (i.E. less than 100 ms) and may not be detected by quality control and internal standard value monitoring.

Device

WATERS MASS SPECTROMETER - ACQUITY TQD IVD
  • Modelo / Serial
    Model Catalog: 186003875IVD (Lot serial: QBB1290); Model Catalog: 186004490IVD (Lot serial: VBA521); Model Catalog: 186003875IVD (Lot serial: QBB1147); Model Catalog: 186003875IVD (Lot serial: QBB1122); Model Catalog: 186003875IVD (Lot serial: QBB1050); Model Catalog: 186004490 (Lot serial: VBA607); Model Catalog: 186004490 (Lot serial: VBA200); Model Catalog: 186004490 (Lot serial: VBA198); Model Catalog: 186004490 (Lot serial: VBA066); Model Catalog: 186004490 (Lot serial: VBA021); Model Catalog: 186003875 (Lot serial: QBB1227); Model Catalog: 186003875 (Lot serial: QBA625); Model Catalog: 186003875 (Lot serial: QBA613); Model Catalog: 186003875 (Lot serial: QBA546); Model Catalog: 186003875 (Lot serial: QBA427); Model Catalog: 186003875 (Lot serial: QBA369); Model Catalog: 186003875 (Lot serial: QBA327); Model Catalog: 186003875 (Lot serial: QBA122D); Model Catalog: 186003250 (Lot serial: VAB807); Model Catalog: 186003250 (Lot serial: VAB488); Model Catalog: 186003250 (Lot serial: VAB451); Model Catalog:
  • Descripción del producto
    Acquity TQD IVD Mass Spectrometer
  • Manufacturer
    WATERS CORPORATION

Manufacturer

WATERS CORPORATION
  • Dirección del fabricante
    MILFORD
  • Empresa matriz del fabricante (2017)
    Waters Corporation
  • Source
    HC