Events

Retiro De Equipo (Recall) de Clinitek Status

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
    69228
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0082-2015
  • Fecha de inicio del evento
    2014-09-19
  • Fecha de publicación del evento
    2014-10-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-07-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129980
  • 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
    Method, enzymatic, glucose (urinary, non-quantitative) - Product Code JIL
  • Causa
    The external power supply for the clintek status analyzer, which is provided separately, is damaged. it can result in an electric shock to the user.
  • Acción
    Siemens sent an Urgent Field Safety Notice dated September 2014, to all by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on September 19, 2014 both in the United States and elsewhere for communication with affected customers. This notice informs customers of the issue with the power supply and the potentially affected products that may contain a damaged power supply. Consignees are asked to complete a Field Correction Effectiveness Check form and return in to Siemens Healthcare Diagnostics via Fax to (312) 275-7795. All affected domestic customers were sent a hard copy of the Urgent Field Safety Notice via Federal Express on 9/23/14. All affected customers outside the US will be provided a copy of an Urgent Field Safety Notice via hard copy, e-mail, and/or fax as determined by each countries local regulations and procedures. Customers with questions were instructed to contact their local Siemens technical support representative. For questions regarding this recall call 877-229-3711.

Device

Clinitek Status
  • Modelo / Serial
    10703923, 10704041, 10376322, 10376323, 10470849; (Legacy P/N: 1797, 1790) Power supply adaptors embossed with the following numerical date codes: 50130, 51130, 52130, 01140, 02140, 03140, 04140, 05140, 06140, 07140, 08140, 09140, 10140, 11140, 12140, 13140, 14140, 15140, 16140, 17140, 18140, 19140, 20140, 21140, 22140, 23140
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) including Puerto Rico and Internationally Canada, Mexico, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Great Britain, Greece, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Latvia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Qatar, Republic Korea, Romania, Russian Fed., Saudi Arabia, Senegal, Singapore, Slovakia, Slovenia, South Africa, Sweden, Switzerland, Tadjikistan, Taiwan, Turkey, Turkmenistan, Unit.Arab Emir., United Kingdom, Vietnam.
  • Descripción del producto
    External power supply adaptors that accompany Clinitek Status Connect System || The Clinitek Status system is a urine analyzer.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc

Manufacturer

Siemens Healthcare Diagnostics, Inc
  • Dirección del fabricante
    Siemens Healthcare Diagnostics, Inc, 333 Coney St, East Walpole MA 02032-1516
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA