Events

Retiro De Equipo (Recall) de Device Recall ADVIA Centaur TSH3Ultra

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
    79496
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2054-2018
  • Fecha de inicio del evento
    2017-12-18
  • 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=162477
  • 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
    Radioimmunoassay, thyroid-stimulating hormone - Product Code JLW
  • Causa
    In certain scenarios the advia centaur cp, xp and xpt immunoassay analyzers may exhibit reduced dilution recovery or become inoperable when used with multi-diluent 15 and certain lots of bnp and tsh3rul assays.
  • Acción
    Consignees are asked to return the response form and follow the instructions pertaining to their system and assays: Actions for ALL ADVIA Centaur Systems: Do not perform onboard dilutions on any ADVIA Centaur system if any of the affected kits are present on the system. Onboard dilutions for the ADVIA Centaur BNP and/or TSH3UL assay(s) are only supported when using ADVIA Centaur BNP kit lots ending in 210 and above and ADVIA Centaur TSH3UL kit lots ending in 310 and above. Actions for ADVIA Centaur XPT system: If you intend to perform onboard dilutions for the ADVIA Centaur BNP and/or TSH3UL assays, you must restart the workstation after scanning the master curve card for the BNP and/or TSH3UL assay kit lot, before ordering an onboard dilution for these assays. Please perform the attached steps to restart the workstation. Actions for ADVIA Centaur CP system: If any of the affected kit lots have been in use on the system, you must manually track the time that the Multi-Diluent 15 has been in use on board the system. Replace the ancillary pack of Multi-Diluent 15 every 7 days when used, until a follow-up communication is received from Siemens stating this issue has been resolved.

Device

Device Recall ADVIA Centaur TSH3Ultra
  • Modelo / Serial
    Lot Numbers ending in: 298 and 301
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in the following U.S. states: AL, CA, DE, GA, IA, IL, IN, KY, MA, MI, MS, MT, NC, ND, NJ, NM, NV, NY, OH, PA, RI, TN, TX, VA, WA, WV, WY and Puerto Rico. Distributed in the following OUS countries: Australia Belgium¿¿¿¿¿¿¿¿ Canada Chile France¿¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Greece¿¿¿¿¿¿¿¿¿ Israel Italy¿¿¿¿¿¿¿¿¿¿ Japan Latvia¿¿¿¿¿¿¿¿¿ Luxembourg¿¿¿¿¿ Netherlands¿¿¿¿ New Zealand Norway¿¿¿¿¿¿¿¿¿ Poland¿¿¿¿¿¿¿¿¿ Portugal¿¿¿¿¿¿¿ Romania¿¿¿¿¿¿¿¿ Singapore Slovakia¿¿¿¿¿¿¿ South Africa Spain¿¿¿¿¿¿¿¿¿¿ Switzerland¿¿¿¿ U.A.E.¿¿¿¿¿¿¿¿¿ United¿Kingdom¿
  • Descripción del producto
    ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra), Catalog Numbers: 06491072 (100 tests), 06491080 (500 tests), 04862625 (2500 tests)
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Dirección del fabricante
    Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA