Events

Retiro De Equipo (Recall) de Device Recall IMMULITE /IMMULITE 1000 Folic Acid

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
    66713
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0569-2014
  • Fecha de inicio del evento
    2013-11-06
  • Fecha de publicación del evento
    2013-12-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123046
  • 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
    Acid, folic, radioimmunoassay - Product Code CGN
  • Causa
    Potential for an accelerated decline in counts per second (cps) for three immulite/immulite 1000 folic acid kit lots. this may lead to a failed adjustment before the labeled expiration date is reached.
  • Acción
    Siemens sent an Urgent Medical Device Correction notices dated November 7 2013, via FedEx to the US customers. The letter identified the product the problem and the action needed to be taken by the customers. Customers are instructed that If the adjustment slope is less than or equal to 1.8 and quality control results are within the established ranges, the kit may be used to generate patient results. If the adjustment slope is greater than 1.8, customers are instructed to discontinue use and discard the kit lots. Ex-US distribution is determined at the country level. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within thirty (30) days. Field service personnel were sent a support document describing the issue and instructing them how to deal with customer questions. For further questions please call CUSTOMER CARE CENTER NUMBER: (302) 631-7597.

Device

Device Recall IMMULITE /IMMULITE 1000 Folic Acid
  • Modelo / Serial
    Kit Lots 335, 336, and 337
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of Argentina, Bosnia-Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Denmark, Dominican Republic, Estonia, France, Germany, Great Britain, Greece, Guatemala, Hungary, India, Italy, Latvia, Mexico, Netherlands, Panama, Paraguay, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Tunisia, United Arab Emirates, Uzbekistan and Venezuela.
  • Descripción del producto
    IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 tests), Siemens Material Number (SMN) 10380902, IVD; for in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers --- Siemens Healthcare Diagnostics Products Ltd. || An IVD for the quantitative measurement of folic acid in serum, heparinized plasma or ascorbic acid-treated whole blood, as an aid in clinical diagnosis and treatment of anemia.
  • Manufacturer
    Siemens Healthcare Diagnostics

Manufacturer

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