Events

Retiro De Equipo (Recall) de Device Recall MUM1BC5, Concentrated and Prediluted Rabbit Monoclonal antibody

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 Biocare Medical Llc.

¿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
    70010
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0965-2015
  • Fecha de inicio del evento
    2014-12-12
  • Fecha de publicación del evento
    2015-01-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-03-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132108
  • 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
    Immunohistochemistry reagents and kits - Product Code NJT
  • Causa
    Three lots of mum-1 may not meet their labeled shelf life, as a drop in staining intensity over time has been observed.
  • Acción
    Biocare sent a Medical Device Recall notifications letter to all customers by traceable method. The letters identified the affected product, problem and actions to be taken. Users are asked to immediately discontinue used of the affected lots and dispose of them according to applicable national, state and local laws. Users are requested to complete and return the response form so that proper credit can be issues 800-799-9499.

Device

Device Recall MUM1BC5, Concentrated and Prediluted Rabbit Monoclonal antibody
  • Modelo / Serial
    Lot 061013, Exp 2016/06; Lot 073013, Exp. 2016/07; Lot 071614, Exp. 2017/07.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distrinution - US Nationwide in the states of TX, WI, MO, WV, SC, MA, WA, TN, AZ, CA, IL, NY, LA and countries of Kuwait, India, Venezuela, New Zealand, Turkey, Uruguay.
  • Descripción del producto
    MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA; || Product Usage: For In Vitro Diagnostic Use. This antibody may be used as a tool for the identification and the sub classification of lymphoid malignancies || : || Multiple myeloma oncogene-1 (MUM-1) is a protein encoded by MUM-1 gene. MUM-1 protein is expressed in the nuclei and cytoplasm of plasma cells and a small percentage of germinal center (GC) B-cells located in the light zone. MUM-1 [BC5] labels MUM-1protein in centrocytes and their progeny, plasma cells, activated T-cells and a wide spectrum of hematolymphoid neoplasms derived from these cells. MUM-1 has been reported to play an important role in mediating B-cell activation and differentiation.
  • Manufacturer
    Biocare Medical Llc

Manufacturer

Biocare Medical Llc
  • Dirección del fabricante
    Biocare Medical Llc, 4040 Pike Ln, Concord CA 94520-1227
  • Empresa matriz del fabricante (2017)
    Biocare Medical LLC
  • Source
    USFDA