Events

Rappel de Device Recall BD Tritest CD3 FITC/CD PE/CD45 PerCP (IVD)

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
    74788
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-2378-2016
  • Date de mise en oeuvre de l'événement
    2016-07-18
  • Date de publication de l'événement
    2016-08-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148462
  • 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
    Counter, differential cell - Product Code GKZ
  • Cause
    Internal review found that some vials of cd3/cd4/cd45 state that the product contains gelatin. the product does not contain gelatin and should state in buffer.
  • Action
    BD Life Sciences sent an Urgent Product notification letter dated July 18, 2016 to all affected customers via UPS and/or e-mail. The letter informed the user of the issue and states that no action is required since product performance is not impacted. The response form is to be returned to BD as instructed. Customers requiring further assistance were instructed to contact BD Customer Support at 855-236-2772. For questions regarding this recall call 408-954-6080.

Device

Device Recall BD Tritest CD3 FITC/CD PE/CD45 PerCP (IVD)
  • Modèle / numéro de série
    Catalog number: 340383; lot No. Expiration Date 49983, 31 July 2016; 01810, 30 September 2016; 82527, 30 September 2016; 54689 , 30 November 2016; 36715 , 31 December 2016; 15614, 31 January 2017; 57797, 28 February 2017.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution to AR, CA, CO, IL, IN, LA, MA, MD, Ml, MN, NC, NJ, NM, NY, OR, PA, TN, TX, WA
  • Description du dispositif
    BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); || Catalog number 340383. || Label states: Contains CD3 FITC/CD4 PE/CD45 per CP with Gelatin and 0.1% sodium azide. || Hematology: || BD Tritest CD3 fluorescein isothiocyanate (FITC)/CD4 phycoerythrin (PE)/CD45 peridinin chlorophyll protein (PerCP) is a three-color direct immunofluorescence reagent for use with a suitably equipped flow cytometer to identify and determine the percentages and absolute counts of mature human T lymphocytes (CD3+) and helper/inducer (CD3+CD4+) Tlymphocyte || subsets in erythrocyte-lysed whole blood.
  • 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