Events

Retiro De Equipo (Recall) de Device Recall OneTouch SureStep Pro

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 Lifescan 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
    54565
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2028-2010
  • Fecha de inicio del evento
    2010-02-24
  • Fecha de publicación del evento
    2010-07-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-12-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88723
  • 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
    system, test, blood glucose, over the counter - Product Code NBW
  • Causa
    Products may provide inaccurate results at readings over 400 mg/dl.
  • Acción
    The firm, Lifescan, Inc., issued two "Urgent Medical Device Recall" letters dated February 24, 2010 to all customers for the OneTouch SureStep Test Strips and the SureStep Pro Test Strips. The letters describes the product, problem and action to be taken by the customers. The customers were instructed to look at your test strip vials for the recalled lots and check the strips or if you have test strips from the lot, call LifeScan Customer Service at 800-574-6139 between 5 a.m. to 7 p.m. Pacific Time, seven days a week or visit www.SureStep.com. Replacement product will be shipped to you immediately at no charge. The customers were instructed to continue to test your blood glucose, while wafting for replacement. Also, the customers are asked to continue use of the meter with precautions if results over 400 units are observed. For more information, please visit www.SureStep.com or call our Healthcare Professional Line at 888-455-5627.

Device

Device Recall OneTouch SureStep Pro
  • Modelo / Serial
    Part Number 01079702, lot numbers 2960713004 2960714009 2960715009 2963504009 2963590009 2963591009 2963592009 2965254009 2965255009 2966650004 2966682009 2966967009 2967057009 2967292009 2967293009 2967849009 2967850009 2967851004 2968029009 2968058004 2968059009 2968060009 2968521008 2968522009 2968523009 2968907009 2969686009 2970097009 2970582009 2975839008 2975840009 2977745008 2977746008 2982027008 2982028008 2982029009 2982366009 2983580009 2984289008 2984956009 2985665008 2985721004 2986875004 2987194009 2987195004 2988277009 2988392009 2990530009 2990940009 2991535009 2992027010 2992293009 2992433011 2992544009 2992695010 2992815010 2992816011 2993127010 2993235010 2993294010 2993295011 2993425011 2993426010 2993599011 2993600011 2993739010 2993991011 2994157010 2994235011 2994236010 2994281004 2994317011 2994463010 2994650010 2994659010 2994704011 2994739010 2994811010 2994812009 2994938011 2998321010 2998322011 2998731011 2999850010 3000111010 3000377011 3000723011 3000724011 3002101010 3002236010 3002237010 3002359010 3003574010 3003632011
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA and countries of Europe, Latin America and Asia.
  • Descripción del producto
    OneTouch SureStep Pro Test strips, for use with the OneTouch SureStep Pro Blood Glucose Meters, in 50 count packaging distributed by LifeScan Inc., Milpitas, CA, Manufactured by LifeScan Puerto Rico || Medical device for quantitative measurement of glucose in whole blood for use in hospital and clinical settings. The product is also for use in quantitative measurement of glucose in venous, capillary, arterial and neonatal whole blood samples. This system can also be used by lay users at home.
  • Manufacturer
    Lifescan Inc

Manufacturer

Lifescan Inc
  • Dirección del fabricante
    Lifescan Inc, 1000 Gibraltar Dr, Milpitas CA 95035
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA