Events

Retiro De Equipo (Recall) de BioRad D10 Hemoglobing Testing System

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 Bio-Rad Laboratories, Inc., Hercules, CA.

¿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
    56807
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1969-2011
  • Fecha de inicio del evento
    2010-09-08
  • Fecha de publicación del evento
    2011-04-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94554
  • 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
    Assay, glycosylated hemoglobin - Product Code LCP
  • Causa
    The firm discovered that the update kit floppy diskette included in the reorder pack was mislabeled with an incorrect lot number for the calibrator/diluent set as: s01819; the correct lot number for the calibrator/diluent set is: s01704.
  • Acción
    The Bio-Rad Laboratories, Inc, sent a Medical Device Correction letter dated 9/8/10, to all affected customers via Federal Express addressing this mislabeling issue, a new Update Kit Floppy Diskette, Lot No. BA02210 has been produced, and Bio-Rad requests that you please destroy the Lot No. AA01815. If you have any questions please contact your regional Bio-Rad office. You may also call (510) 724-7000.

Device

BioRad D10 Hemoglobing Testing System
  • Modelo / Serial
    Lot 20001814; Exp. February 28,2012
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including : PA, OH, MO, CA, TX, FL, MA, MD, KY, OH, MI, NJ, and WA.
  • Descripción del producto
    Bio Rad brand D-10 Hemoglobin A1c Program Reorder Pack, which contains Update Kit D-10 A1c Program Diskette; || Model Numbers: 220-0101 (Reorder Pack); 220-0115 (Program Diskette); Distributed and manufactured by: Bio-Rad Laboratories, Inc., Hercules, CA || System Overview: The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, A1 c) in whole blood. The separation is based on the principles of high performance liquid chromatography. Technology Overview: The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis in mid-volume laboratories. The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-1 0 incorporates the use of a dedicated software system for instrument control, data collection and analysis. The D-10 Software performs reduction of raw data collected from each analysis. Reagent Kit Information: The D-10 Hemoglobin A1c Program utilizes principles of ion-exchange High-performance liquid chromatography (HPLC). The D-10 Hemoglobin Ale Program is based on chromatographic separation of HbA1c on a cation exchange cartridge. The Bio-Rad D-10 Hemoglobin Ale Program is intended for the percent determination of hemoglobin A1 c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). The Bio-Rad D-10 Hemoglobin A1c Program is intended for Professional Use Only. The D-10 Hemoglobin A1c Program is for use only with the Bio-Rad D-10 Hemoglobin Testing System.
  • Manufacturer
    Bio-Rad Laboratories, Inc., Hercules, CA

Manufacturer

Bio-Rad Laboratories, Inc., Hercules, CA
  • Dirección del fabricante
    Bio-Rad Laboratories, Inc., Hercules, CA, 4000 Alfred Nobel Dr, Hercules CA 94547-1803
  • Empresa matriz del fabricante (2017)
    Bio-Rad Laboratories Inc
  • Source
    USFDA