Events

Retiro De Equipo (Recall) de Siemens Chemistry Calibrator used with the ADVIA Chemistry Direct Bilirubin 2 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.

¿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
    66396
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0365-2014
  • Fecha de publicación del evento
    2013-11-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-05-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122248
  • 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
    Diazo colorimetry, bilirubin - Product Code CIG
  • Causa
    Siemens healthcare diagnostics is conducting a field correction for siemens chemistry calibrator lots 090445b and 090445c on the advia 1200, 1650, 1800, and 2400 chemistry systems. the system specific values (ssvs) for the direct bilirubin assay (dbil_2) have been reassigned for these lots. siemens has determined that the dbil_2 ssvs currently assigned to these lots may cause an average shift of.
  • Acción
    Siemens Healthcare Diagnostics sent an Urgent Medical Device Correction Letters dated September 24, 2013 and Response Forms to the US consignees via FedEx. Urgent Field Safety Notices were also distributed to customers outside the US. Customers are instructed to use the reassigned System Specific Values for the affected lots listed in the letter. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Recall letter within thirty (30) days. The questionnaire is to be faxed to the Technical Solutions Center at 302-631-7597. On September 30, 2013, Siemens sent a revised customer notifications to correct the Part Number.

Device

Siemens Chemistry Calibrator used with the ADVIA Chemistry Direct Bilirubin 2 Reagent
  • Modelo / Serial
    Lots 090445B (exp. 07/2014) and 090445C (exp. 10/2014)
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA Nationwide in the states of: Argentina, Austria, Belgium, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, France, French Polynesia, Germany, Guadeloupe, Guatemala, Great Britain, Greece, Korea, Indonesia, Israel, Italy, Kazakhstan, Latvia, Liechstenstein, Lithuania, Luxembourg, Macedonia, Martinique, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Russian Federation, Serbia, Singapore, Slovenia, Slovakia, Spain, Sweden, Switzerland, Thailand, Taiwan, Tunisia, Turkey, United Arab Emirates, Uruguay, Vatican City, and Vietnam.
  • Descripción del producto
    Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubin_2 Reagent, Siemens Material Number (SMN) 10312279, REF 09784096, Part Number T03-1291-62; IVD || Product usage: Usage: || DBIL_2: For in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA Chemistry systems. Such measurements are useful in the screening of liver function disorders or in the diagnosis of jaundice.
  • Manufacturer
    Siemens Healthcare Diagnostics

Manufacturer

Siemens Healthcare Diagnostics
  • Dirección del fabricante
    Siemens Healthcare Diagnostics, 511 Benedict Ave, Tarrytown NY 10591-5005
  • Source
    USFDA