Events

Retiro De Equipo (Recall) de Device Recall Dimension Vista/Blood Urea Nitrogen Flex/BUN

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
    73592
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1622-2016
  • Fecha de inicio del evento
    2016-02-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-12-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144544
  • 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
    Urease and glutamic dehydrogenase, urea nitrogen - Product Code CDQ
  • Causa
    Siemens healthcare diagnostics has determined that dimension vista blood urea nitrogen (bun) lots 15215ae, 15243bb, 15264ba, 15299bb, 15300ba and 15341ac may exhibit inaccurate patient and/or quality control results. the issue has been isolated to flex reagen cartridges manufactured from specific mold cavities.
  • Acción
    Siemens Healthcare sent an Urgent Medical Device Correction letter dated February 2016, to all affected customers. It was determined that Dimension Vista Blood Urea Nitrogen (BUN) lots 15215AE, 15243BB, 15299BB, 15300BA, 15320BB and 15341AC may exhibit inaccurate patient and/or Quality Control results. The issue has been isolated to Flex reagent cartridges manufacture from specific mold/cavity identifies as described in Table 2 of the Urgent Medical Device Correction notification sent to customers. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative. For further questions, please call (302) 631-0528.

Device

Device Recall Dimension Vista/Blood Urea Nitrogen Flex/BUN
  • Modelo / Serial
    Device Listing # D011374, Lot # 15341AC, 15320BB, 15300BA, 15299BB, 15264BA, 15243BB and 15215AE
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution - US (nationwide) distribution including Puerto Rico and to the states of : AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. , and to the countries of : Canada, United Arab Emir, Australia, Austria, Belgium, Switzerland, Bahamas, Czech Republic, Germany, Denmark, Spain, Finland, France, Italy, Netherland, Norway, Portugal, Slovakia, Slovenia, Japan, Republic of Korea, New Zealand.
  • Descripción del producto
    Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge || The BUN method is an in vitro diagnostic test for the quantitative measurement of urea nitrogen (an end product of nitrogen metabolism) in human serum, plasma, and urine on the Dimension Vista System.
  • 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