Events

Retiro De Equipo (Recall) de Dimension Vista Gentamicin Flex reagent cartridge

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
    80009
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2182-2018
  • Fecha de inicio del evento
    2018-04-19
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164206
  • 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
    Enzyme immunoassay, gentamicin - Product Code LCD
  • Causa
    The affected lots may exhibit inaccuracy for quality control and patient samples at the low end of the analytical measurement range. the bias is due to the calibration curve not showing separation between the level 1 and level 2 calibrators. the negative bias observed for patient, qc, and calibrator samples, when using any of the listed lots, has the potential to impact the interpretation of gentamicin results during therapeutic monitoring at concentrations up to approximately 2.5 ¿g/ml [5.4 ¿mol/l].
  • Acción
    On April 19, 2018, the firm sent an Urgent Medical Device Recall letter to customers. The letter identified the affected lots and advised customers to do the following: Inspect stock, discontinue use of and discard the Dimension and Dimension Vista GENT lots listed in Table 1. ¿ Please review this letter with your Medical Director. ¿ Review your inventory of these products to determine your laboratorys replacement needs and to provide information to Siemens for reporting to the regulatory authorities. ¿ Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. ¿ If you have received any complaints of illness or adverse events associated with the product listed in Table 1, immediately contact your local Siemens Customer Care Center or your local Siemens Technical Support Representative.

Device

Dimension Vista Gentamicin Flex reagent cartridge
  • Modelo / Serial
    Lots 17135BC 17150BF 17159BD 17178AC 17269BD 17312BB
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution. Foreign distribution to Argentina, Australia, Brazil, Bahamas, Canada, Germany, India, Japan, Myanmar, New Zealand, Saudi Arabia, Taiwan, and South Africa.
  • Descripción del producto
    Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay. Affected lots are 17135BC, 17150BF, 17159BD, 17178AC, 17269BD, and || 17312BB.
  • 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