Events

Retiro De Equipo (Recall) de Device Recall Siemens Emit(R) tox(TM) Serum Calibrators

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
    63941
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0665-2013
  • Fecha de inicio del evento
    2012-12-06
  • Fecha de publicación del evento
    2013-01-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-12-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115082
  • 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
    Calibrators, drug mixture - Product Code DKB
  • Causa
    Incorrect expiration date was assigned to the d1 lot of emit(r) tox(tm) serum calibrators. the correct expiration date is 2013-12-31. the incorrect assigned expiration date is 2014-12-31.
  • Acción
    Siemens sent a Customer Notification letter dated December 2012 to all affected customers of Emit(R) tox(TM) Serum Calibrators lot D1, informing them that Siemens Healthcare Diagnostics, Inc. has confirmed that the expiration of 2014-12-31 is incorrect. Siemens requested customers to discontinue use and discard any remaining inventory of the D1 lots. Customers were instructed to complete the Effectiveness Check form included with the letter even if no replacement reagents were needed and fax to 302-631-8467. Siemens would replace any unused kits of the affected lots at no charge. Customers with questions were instructed to contact their Siemens Technical Solutions Center or their local Siemens technical support representative. For questions regarding this recall call 302-631-6311.

Device

Device Recall Siemens Emit(R) tox(TM) Serum Calibrators
  • Modelo / Serial
    Lot D1
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to the following states: AL, AR, CA, CO, FL, GA, IL, IN, KY, MA, MD, MI, MO, NC, NY, OH, PA, TN, TX and WI.
  • Descripción del producto
    Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL || The Emit(R) tox(TM) Serum Calibrators are intended for use with the Emit(R) tox(TM) Serum Barbiturate and Benzodiazepine Assays as a reference for the semi-quantitative analis of barbiturates and benzodiazepines in human serum.
  • 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