Events

Retiro De Equipo (Recall) de Siemens Healthcare Diagnostics Dimension Vista HbA1c Flex reagent cartridge and HB1C Flex reagent

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
    69434
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0420-2015
  • Fecha de publicación del evento
    2014-11-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130530
  • 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
    Assay, glycosylated hemoglobin - Product Code LCP
  • Causa
    Certain lots of the reagent cartridges show confirmed positive bias averaging 0.4% hemoglobin a1c units and occasionally up to 1.0% hba1c units for patient samples when compared to the national glycohemoglobin standardization program (ngsp). qc samples may exhibit a similar bias.
  • Acción
    Siemens sent an Urgent Medical Device Correction letter dated September 2014 was provided to all Dimension Vista¿ HbA1c and Dimension¿ HB1C customers who received the affected lots to notify them of the issue, the potential risk to health, and actions to be taken by customers. Customers were instructed to discontinue use of and discard the affected devices. Customers need to review the letter with their Medical Director. Siemens will replace any unused inventoryof the affected lots at no charge. Customers were asked to complete the attached form and fax it to 302-631-7795. Customers should retain a copy of the letter with their laboratory records, and forward the letter to those who may have received this product. Customers with questions should contact their Siemens Customer Care Center - Technical Solutions or their local Siemens technical support representative. For questions regarding this recall call 800-441-9250.

Device

Siemens Healthcare Diagnostics Dimension Vista HbA1c Flex reagent cartridge and HB1C Flex reagent
  • Modelo / Serial
    Siemens Dimension Vista HbA1c Flex reagent cartridge: Catalog Number K3105A, Siemens Material Number (SMN) 10470481, Lot Numbers 13294BA 13308BA 13329AA 13350AA 14006AA 14041BA 14069BB 14083BA   Siemens Dimension HB1C Flex reagent cartridge: Catalog Number DF105A, Siemens Material Number (SMN) 10483822, Lot Numbers GA4266 BA4273 BA4280 BA4287 GA4301 GA4315 GC4322 GA4343 GA4350 GA4357 GA5013 GA5020
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) and internationally to: Canada.
  • Descripción del producto
    Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long-term glucose control in individuals with diabetes mellitus.
  • 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