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

  • Model / Serial
    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.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution to AR, CA, CO, IL, IN, LA, MA, MD, Ml, MN, NC, NJ, NM, NY, OR, PA, TN, TX, WA
  • Product Description
    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
  • 1 Event

Manufacturer

  • Manufacturer Address
    Becton, Dickinson and Company, BD Biosciences, 2350 Qume Dr, San Jose CA 95131-1812
  • Manufacturer Parent Company (2017)
  • Source
    USFDA