Events

Rappel de BD 79b (SN8) phycoerythrin (PE)

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 Becton, Dickinson and Company, BD Biosciences.

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
    75250
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0128-2017
  • Date de mise en oeuvre de l'événement
    2016-09-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-12-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149794
  • 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
    Reagents,specific,analyte - Product Code MVU
  • Cause
    Cd79b (sn8) pe is contaminated with a fitc conjugate of unknown antigenic specificity.
  • Action
    BD Life Sciences sent an Urgent Product recall letter dated September 2016 on September 21, 2016 ,to all affected customers via UPS and/or e-mail. Customers were instructed to inspect their inventory to determine if they have any of the affected lots and to discard the affected lots, and BD will issue replacement product. Customers were also instructed to complete the attached Customer Response Form whether or not they have any affected product. Customers needing further assistance should contact BD Customer Support at 855-236-2772 (prompt 3). For customers outside the US, contact their local BD Biosciences representative or distributor. For questions regarding this recall call 408-954-6307.

Device

BD 79b (SN8) phycoerythrin (PE)
  • Modèle / numéro de série
    Lot number: 5348570; Expiration Date: 31 July 2017
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution to CA, MN, OH and TX.
  • Description du dispositif
    CD79b PE (ASR) , Catalog number 335816 ; || Hematology: || The CD79b antibody recognizes an epitope on the extracellular domain of a 3640 kilodalton (kDa) type I membrane glycoprotein. Immunoglobulin (Ig) antigen receptors are composed of a non-covalently associated complex of Ig and two other proteins, Iga and Igb, which have been designated as CD79a and CD79b, respectively. || antigen
  • Manufacturer
    Becton, Dickinson and Company, BD Biosciences

Manufacturer

Becton, Dickinson and Company, BD Biosciences
  • Adresse du fabricant
    Becton, Dickinson and Company, BD Biosciences, 2350 Qume Dr, San Jose CA 95131-1812
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA