Events

Retiro De Equipo (Recall) de Device Recall Dropper Plus PointofCare Urinalysis Dipstick Control kit

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Quantimetrix 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
    80179
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2257-2018
  • Fecha de inicio del evento
    2017-12-21
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164785
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Urinalysis controls (assayed and unassayed) - Product Code JJW
  • Causa
    The kits contained an incorrect lot of dropper plus level 1 vials.
  • Acción
    Communication with their only customer for this recall was via e-mail and phone. Upon notification by the customer the following activities were initiated: All lots of the Dropper Plus product in inventory were 100% inspected. The customer was ask to return all of the kits to Quantimetrix. For further questions please call (310) 536-0006.

Device

Device Recall Dropper Plus PointofCare Urinalysis Dipstick Control kit
  • Modelo / Serial
    Lot 44450E
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution to the state of : Kansas
  • Descripción del producto
    Dropper Plus Point-of-Care Urinalysis Dipstick Control kit || The Quantimetrix Dropper Plus Point-of-Care Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory tests such as K-CHECK and Ictotest reagent tablets, and for hCG methods.
  • Manufacturer
    Quantimetrix Corporation

Manufacturer

Quantimetrix Corporation
  • Dirección del fabricante
    Quantimetrix Corporation, 2005 Manhattan Beach Blvd, Redondo Beach CA 90278-1205
  • Empresa matriz del fabricante (2017)
    Quantimetrix Corporation
  • Source
    USFDA