Device Recall Hemoglobin Reagent Syringe Used on the CELLDYN Sapphire Automated Hematology Analyzer

  • Model / Serial
    All Hemoglobin Reagent Syringes, List No. 08H49-02, with packaging dates between May 8,2007 and November 29,2007. Each package is identified with product description "CDS HGB SRNG W/BU".
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA including states of AR, AZ, CA, GT, FL, GA, ID, IL, KY, LA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OM, OR, PA, SC, TN, TX, UT, VA, WI, and WV and countries of Canada, Mexico, Australia, Brazil, Canada, China, Chile, Columbia, Germany, Hong Kong, Japan, Mexico, Peru, Singapore, and South Korea.
  • Product Description
    CELL-DYN Hemoglobin Reagent Syringe used on the CELL-DYN Sapphire Automated Hematology Analyzer. Abbott Labs, Abbott Park, IL.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Abbott Laboratories, 5440 Patrick Henry Dr, Santa Clara CA 95054-1113
  • Source
    USFDA