Events

Retiro De Equipo (Recall) de Device Recall ADVIA Centaur Vitamin D Diluent 2pack

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
    61236
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1268-2012
  • Fecha de inicio del evento
    2012-02-16
  • Fecha de publicación del evento
    2012-03-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-10-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107628
  • 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
    System, test, vitamin d - Product Code MRG
  • Causa
    Automatic and system-performed dilution calculation factor for vitamin d dilutions is incorrect and causes diluted patient samples to under recover by approximately 50%.
  • Acción
    The firm, Siemens Healthcare Diagnostics, sent an "Urgent Device Recall Notice" on February 16, 2012 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to discontinue using the automatic and system-performed dilution features for Vitamin D; to discontinue the use of ADVIA Centaur VitD Diluent, 2-pack (REF 10494100); to manually dilute samples with values greater than the assay range of 150 ng/mL (375 nmoI/L), using the ADVIA Centaur VitD Diluent, 1 bottle (REF 10632114) as stated in the Vitamin D assay Instructions For Use (IFU); to review the contents of the recall notice with their Laboratory Director and retest the previous sample results generated using system- performed dilutions, and complete and return the confirmation fax-back form via fax to TECHNICAL SOLUTIONS CENTER at (302) 631-7597. If you have any questions or need additional information, please contact your local Technical Support Provider or Distributor or call (508) 668-5000.

Device

Device Recall ADVIA Centaur Vitamin D Diluent 2pack
  • Modelo / Serial
    Lot # 80230 Expiry Date 04 May 2012
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries of: Columbia, China, Denmark, Egypt, and Hong Kong.
  • Descripción del producto
    Siemens ADVIA Centaur Vitamin D Diluent 2-pack, || Reference 10494100 || in vitro diagnostic use in the quantitative determination of total || 25 (OH) vitamin D in human serum and plasma (EDTA, lithium-heparin, sodium heparin) using the ADVIA Centaur and ADVIA Centaur XP systems || The ADVIA Centaur Vitamin D Total (Vit D) assay is for in vitro diagnostic use in the quantitative determination of total 25 (OH) vitamin D in human serum and plasma (EDTA, lithium-heparin, sodium heparin) using the ADVIA Centaur and ADVIA Centaur XP systems. The ADVIA Centaur Vit Assay is intended as an aid in the determination of vitamin D insufficiency. The ADVIA Centaur Vitamin D Diluent 2-pack is used on board the ADVIA Centaur systems to perform automatic and system-performed dilutions fro Vitamin D assay.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc

Manufacturer

Siemens Healthcare Diagnostics, Inc
  • Dirección del fabricante
    Siemens Healthcare Diagnostics, Inc, 333 Coney St, East Walpole MA 02032-1516
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA