Events

Rappel de BioRad D10 Hemoglobing Testing System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Bio-Rad Laboratories, Inc., Hercules, CA.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    56807
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1969-2011
  • Date de mise en oeuvre de l'événement
    2010-09-08
  • Date de publication de l'événement
    2011-04-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-06-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94554
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Assay, glycosylated hemoglobin - Product Code LCP
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    Lot 20001814; Exp. February 28,2012
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including : PA, OH, MO, CA, TX, FL, MA, MD, KY, OH, MI, NJ, and WA.
  • Description du dispositif
    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
  • Adresse du fabricant
    Bio-Rad Laboratories, Inc., Hercules, CA, 4000 Alfred Nobel Dr, Hercules CA 94547-1803
  • Société-mère du fabricant (2017)
    Bio-Rad Laboratories Inc
  • Source
    USFDA