Events

Retiro De Equipo (Recall) de Device Recall Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine

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
    63809
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0636-2013
  • Fecha de inicio del evento
    2012-11-21
  • Fecha de publicación del evento
    2013-01-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-11-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114818
  • 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
    When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25¿c (77¿f).
  • Acción
    Siemens issued An Urgent Field Safety Notice via e-mail to all affected SiemensHealthcare Diagnostics Regional offices on November 21, 2012 both in the United States and foreign accounts. This notice informed customers of the issue with the CLINITEK Atlas¿ and Chek-Stix¿ Positive Urinalysis Control Solutions When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25¿C (77¿F). You can use the reconstituted positive control solution for up to eight hours if the solution is held at 25¿C (77¿F) or lower. If the operating temperature is greater than 25¿C and lower than 30¿C (77¿F and 86¿F), the solution can be used for up to two hours. For questions regarding this recall call 781-269-3158.

Device

Device Recall Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine
  • Modelo / Serial
    Carton/Bottle Lot Number: S9093061A P9093061A  S9094081A P9094081A  S0097091C P0097091C  S9093061A P9093061A S9094081A P9094081A  S0097091C P0097091C  S0100101B P0100101B  S0103042A P0103042A  S0103042H P0103042H  S0106062A P0106062A  S9101022A P9101022A  S9101022B P9101022B  S9105052A P9105052A
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and internationally to Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore,Thailand, Bahamas, South Wales, and Hong Kong,
  • Descripción del producto
    Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine || Chemistry || Catalog Number: 5019 || When used with the CLINITEK ATLAS¿ Automated urine Chemistry Analyzer and CLINITEK ATLAS¿ 10 reagent Pak, CLINITEK ATLAS¿ Positive and Negative Control Strips provide defined results for color, clarity, glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogen, nitrite, and leukocytes. Each CLINITEK ATLAS Positive Control Strip is a firm plastic strip to which are affixed seven separate analyte areas.
  • Manufacturer
    Siemens Healthcare Diagnostics Inc

Manufacturer

Siemens Healthcare Diagnostics Inc
  • Dirección del fabricante
    Siemens Healthcare Diagnostics Inc, 2 Edgewater Dr, Norwood MA 02062-4637
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA