Events

Retiro De Equipo (Recall) de Device Recall Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61)

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
    64463
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1049-2013
  • Fecha de inicio del evento
    2013-02-22
  • Fecha de publicación del evento
    2013-04-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-01-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116185
  • 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
    Phosphomolybdate (colorimetric), inorganic phosphorus - Product Code CEO
  • Causa
    Siemens healthcare diagnostics has initiated a voluntary field action for dimension(r) phos flex(r) reagent due to reagent interaction causing falsely depressed creatinine results when ezcr is processed from open wells that are in close proximity to open wells of phos reagent.
  • Acción
    Siemens sent an Urgent Medical Device Correction letter dated February 22 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action to be taken by Customer: 1. Customers with two or more Dimension systems should perform testing of PHOS and EZCR on separate Dimension systems. 2. Customers with only one Dimension system should discontinue use of either PHOS or EZCR on the Dimension system. Please contact your local sales representative to discuss alternate solutions that will best meet the needs of your laboratory. Please complete the attached Effectiveness Check form and fax it to the Siemens Technical Solutions Center at (302) 631-8467, to indicate you have received the information. If you have any questions, please contact the Siemens Technical Solutions enter or your local Siemens technical support representative. We apologize for the disruption this situation will cause your laboratory. We are working diligently to resolve this issue with a permanent solution. .

Device

Device Recall Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61)
  • Modelo / Serial
    Lot numbers DC3078, exp 3/19/13; DA3092, exp 4/2/13; FB3109, exp 4/19/13; BC3127, exp 5/7/13; BB3152, exp 6/1/13; EC3166, exp 6/15/13; BB3190, exp 7/9/13; DA3212, exp 7/31/13; EA3233, exp 8/21/13; FB3260, exp 9/17/13; DA3319, exp 11/15/13; DA3320, exp 11/16/13; GC3337, exp 12/3/13; FB3346, exp 12/12/13; CB4014, exp 1/14/14; and FB4029, exp 1/29/14.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including the states of AK, AL, AR, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
  • Descripción del producto
    Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) || The Phosphorus (PHOS) method used on the Dimension(R) clinical chemistry system is an in vitro diagnostic test intended for the quantitative measurement of phosphorus 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 Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA