Events

Retiro De Equipo (Recall) de DRUGCHECK DRUG SCREEN CUP

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

¿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
    43442
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-04-27
  • 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
    Affected lots of edi's drugs of abuse tests have shown reduced reactivity for up to three (3) of the nineteen (19) benzodiazepine compounds for which specificity information is provided in the product insert. specific compounds for which there may be reduced reactivity include clonazepam nordiazepam and lorazepam. the test continues to perform as expected for other drugs.

Device

DRUGCHECK DRUG SCREEN CUP
  • Modelo / Serial
    Model Catalog: X6XXXXXX (Lot serial: PE-04142); Model Catalog: X6XXXXXX (Lot serial: PE-03190); Model Catalog: X6XXXXXX (Lot serial: PE-02248); Model Catalog: X6XXXXXX (Lot serial: PD-11016); Model Catalog: X6XXXXXX (Lot serial: PE-02220); Model Catalog: X6XXXXXX (Lot serial: PD-12158); Model Catalog: X6XXXXXX (Lot serial: PD-12075); Model Catalog: X6XXXXXX (Lot serial: PD-02271); Model Catalog: X6XXXXXX (Lot serial: PD-12007); Model Catalog: X6XXXXXX (Lot serial: PD-03359); Model Catalog: X6XXXXXX (Lot serial: PD-01224); Model Catalog: X6XXXXXX (Lot serial: PD-02146); Model Catalog: X6XXXXXX (Lot serial: PD-01118); Model Catalog: X6XXXXXX (Lot serial: PD-02268); Model Catalog: X6XXXXXX (Lot serial: PC-12141); Model Catalog: X6XXXXXX (Lot serial: PC-12185); Model Catalog: X6XXXXXX (Lot serial: PD-02270); Model Catalog: X6XXXXXX (Lot serial: PD-03096); Model Catalog: X6XXXXXX (Lot serial: PC-11125); Model Catalog: X6XXXXXX (Lot serial: PD-01119); Model Catalog: X6XXXXXX (Lot serial: PE-05108); Model Catalog:
  • Descripción del producto
    DRUGCHECK DRUG SCREEN CUP
  • Manufacturer
    EXPRESS DIAGNOSTICS INTERNATIONAL INC.

Manufacturer

EXPRESS DIAGNOSTICS INTERNATIONAL INC.