Events

Retiro De Equipo (Recall) de Dimension Vista System (MG)

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 Siemens Healthcare Diagnostics, 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
    72399
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0339-2016
  • Fecha de publicación del evento
    2015-11-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-09-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140938
  • 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
    Photometric method, magnesium - Product Code JGJ
  • Causa
    Erroneous low results on a small number of reagent wells. there is the potential for under-recovery on certain wells for quality control (qc) and patient sample results. the under-recovery ranged from -0.3 mg/dl [0.12 mmol/l] to -1.6 mg/dl [0.66 mmol/l]; equivalent to a maximum negative bias of -88%.
  • Acción
    An Urgent Medical Device Recall dated September 2015 was provided to all Dimension Vista MG customers who received the affected lot to notify them of the issue, the potential risk to health, and actions to be taken by customers. 1. An Urgent Medical Device Recall was provided to all customers who received the affected lot to notify them of the following: Siemens has received customer complaints for Dimension Vista¿ MG lot 15063BA, regarding sporadic depressed serum/plasma and QC results. Discontinue use and discard their remaining inventory of the affected lot. Review the letter with their Medical Director. Siemens will replace any unused inventory of the affected lot.

Device

Dimension Vista System (MG)
  • Modelo / Serial
    Lot Number 15063BA
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distributed US (nationwide) including DC and the states of IL, CA, GA, LA, TX, TN, FL, SC, IA, TN, DE, NJ, WA, MS, KY, NY, WI, OH, OH, MO, UT, KS, VA, AR, WV, MA, PA, AL, CO, IN, MT, NM, ME, AZ, NM, MO, and NC, and the country of Canada.
  • Descripción del producto
    Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista System.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Dirección del fabricante
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA