Events

Retiro De Equipo (Recall) de Calcitonin ELISA Kit

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 Biomerica.

¿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
    69621
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0467-2015
  • Fecha de inicio del evento
    2014-09-18
  • Fecha de publicación del evento
    2014-12-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-03-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131165
  • 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, calcitonin - Product Code JKR
  • Causa
    A potential issue with false high values.
  • Acción
    An Urgent Field Safety Notice dated 9/18/14 was sent to all their customers who purchased the Calcitonin ELISA Kit. The letter informed the customers of the problems identified and the actions to be taken. Customers were to examine their inventory immediately and quarantine any affected product. Also, customers were asked to notify any customers that the product was further distributed to. Customers with questions were instructed to contact their local Customer Service or Sales Representative regarding the recall notification. Customers were instructed to complete and return the enclosed response form by either fax or email as soon as possible and not later than 10/1/14.

Device

Calcitonin ELISA Kit
  • Modelo / Serial
    Lot No. 2041, 2071, 2089, 2124, 2167, 2178, 2180.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, including the states of NH, CA, NJ, FL; and, the countries of Russia, Ukraine, Switzerland, Spain, Italy, Serbia, China, France, Pakistan, Austria, United Kingdom, Egypt, and India.
  • Descripción del producto
    Calcitonin ELISA Kit, Code No. 7024, 7024BU. || Intended use of this product is the quantitative determination of Calcitonin in human serum.
  • Manufacturer
    Biomerica

Manufacturer

Biomerica
  • Dirección del fabricante
    Biomerica, 17571 Von Karman Ave, Irvine CA 92614-6207
  • Empresa matriz del fabricante (2017)
    Biomerica, Inc.
  • Source
    USFDA