Retiro De Equipo (Recall) de Device Recall EliA Sample Diluent, Article number, 83102301

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 Phadia US 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Antibodies, anti-cyclic citrullinated peptide (ccp) - Product Code NHX
  • Causa
    Erroneous elia test results related to problems with liquid level detection and diluent pipetting in phadia 250 instruments, and deformed bottles. investigation showed problems with the liquid level detection in diluent bottle batch jjca resulting in aspiration of no or too low volumes of liquid from the diluent bottle and from the dilution plate.
  • Acción
    Phadia AB, part of Thermo Fisher Scientific, is voluntarily recalling EliA Sample Diluent, Article number, 83-1023-01, lots JM3Y, JS0B, JP87, JK5N, and JU9C, written notices were mailed via FedEx on 01/30/2017. There have been reports of instrument malfunctions for Phadia 250 due to deformed bottles for the below mentioned product and lots. The deformation of the bottle can cause an erroneous volume detection by the instrument which will result in insufficient aspiration of sample diluent, thus generating insufficient dilution of patient samples. The deformation is described as a flange or brim, located on the inside lower part of the vial opening. ACTIONS TO BE TAKEN BY THE CUSTOMER/USER: ¿ Stop using the affected lots of the above mentioned product lots ¿ Please, return or attest to scrapping of any unused product lots to the manufacturer and order replacement products free of charge. ¿ Review your records to determine if you have had instrument problems due to deformed bottles. If you find the instrument error message 3-145 RIGHT ARM LIQUID DETECTION BELOW LOWER LIMIT Target 2, please collect all log files available and/or contact customer support, who will further assist in assessing possible impact on the test results in scope. ¿ Fill in the Medical Device Recall return response on page 3 and return to the manufacturer by e-mail. If customers have any questions, please contact Phadia US, Inc. at 1-800-346- 4364, option #2.


  • Modelo / Serial
    EliA Sample Diluent, Article number, 83-1023-01, lots JM3Y, JS0B, JP87, JK5N, and JU9C
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Domestic: AR, CA, CO, FL, GA, IL, IN, KY, LA, MI, MN, MO, MT, NC, NH, NJ, NM, NY, OH, OR, PA, SD, TN, TX, WI, WV Foreign: None VA/DOD: None
  • Descripción del producto
    EliA Sample Diluent, Article number, 83-1023-01
  • Manufacturer


  • Dirección del fabricante
    Phadia US Inc, 4169 Commercial Ave, Portage MI 49002-9701
  • Empresa matriz del fabricante (2017)
  • Source