Events

Retiro De Equipo (Recall) de Device Recall Dimension Calcium Flex Reagent

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
    59391
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3039-2011
  • Fecha de inicio del evento
    2011-07-19
  • Fecha de publicación del evento
    2011-08-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-12-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102582
  • 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
    Analyzer chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Causa
    Siemens healthcare diagnostic has confirmed a high frequency of "abnormal assay" flags and imprecision. test results across the assay range may be falsely depressed or elevated, as much as, 1.93 mg/dl at a concentration of 9.26 mg/dl.
  • Acción
    An Urgent Field Safety Notice datey July 2011 was issued to all affected customers. Customers are being advised to immediately discontinue use and discard any remaining inventory of Dimension(R) CA Flex(R0 reagent cartridge - lot EA2153. Replacement order for the affected lot is in process, and will be sent to impacted customers free of charge. Customers were instructed to forward the Field Safety Notice to anyone whom they may have distributed the affected product. For questions regarding this recall call 302-631-6299.

Device

Device Recall Dimension Calcium Flex Reagent
  • Modelo / Serial
    Catalog # DF23A; Lot # EA2153
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution to Guam, Puerto Rico, Chile, Costa Rica, Venezuela, South Korea, Vietnam and domestically to AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MN, MI, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WV, WI, and WY.
  • Descripción del producto
    Dimension Calcium Flex Reagent is used on the Dimension clinical chemistry system as an in vitro diagnostic test intended for the quantitive determination of calcium activity in human serum, plasma and urine. || Dimension(R) CA Flex(R) reagent is used on the Dimension(R) clinical chemistry system as an in vitro diagnostic test intended for the quantitative determination of calcium activity in human serum, plasma and urine.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Dirección del fabricante
    Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA