Events

Retiro De Equipo (Recall) de Device Recall SeNova Blood Glucose Test Strips

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 CHdiagnostics.

¿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
    32883
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1546-05
  • Fecha de inicio del evento
    2005-03-14
  • Fecha de publicación del evento
    2005-09-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-01-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41027
  • 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
    Glucose Dehydrogenase, Glucose - Product Code LFR
  • Causa
    A suspect material used in the manufacturer of the product has degraded over time and consequently may cause falsely high readings when testing your blood glucose level.
  • Acción
    Sales Representatives will visit their distribution accounts to ensure affected product is removed. Distributors are asked to follow up with their accounts to ensure that no product is left with their customers. Nursing home customers will be mailed letters detailing the recall and not to use the affected lots.

Device

Device Recall SeNova Blood Glucose Test Strips
  • Modelo / Serial
    Lot numbers: 407061, 4071601, 4071901, 4071902, 4072001, 4072002, 4072201, 4072202, 4072801, 4072802, 4072901, 4072902, 4073001; 4080301, 4080302, 4080303, 4080401, 4080402, 4080601, 4081101, 4081102, 4081601, 4081901, 4082001, 4082002, 4082301, 4082501, 4082502, 4082701, 4083101, 4083102, 4090101, 4090201, 4091601, 4091702, 4092101, 4092201, 4092301, 4092401, 4092701, 4092801, 4092901, 4100101, 4100401, 4100402, 4100501, 4100601, 4101101, 4101201, 4101301, 4101401, 4101801, 4102201, 4102502, 4102601, 4102701, 4102801, 4102901, 4110401, 4110501, 4111101, 4111601 and 4111602.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    AL, FL, IA, IL, IN, KS, MD, MN, MO, MS, ND, NY, OH, PA, SD, TN and WI. Distribution to Greece, Czech Republic and Sinapore is typically done through Cambridge Sensors Limited, United Kingdom.
  • Descripción del producto
    SeNova Test Strips for Testing Glucose in Whole Blood. Blood glucose test strips for use with the Senova brand meter only. For in vitro diagnostics use. Do not store strips outside vial. Discard 3 months after opening. Distributed by CHdiagnostics, Plymouth, MN 55447, USA. Made in U.K.
  • Manufacturer
    CHdiagnostics

Manufacturer

CHdiagnostics
  • Dirección del fabricante
    CHdiagnostics, 1 Carlson Pkwy N, Plymouth MN 55447-4440
  • Source
    USFDA