Device Recall VARIANT II TURBO Link Hemoglobin A1c Program

  • Modèle / numéro de série
    Catalog Number: 270-2716; Reorder Pack Lot No: 70210702; Expires September 30, 2011. Elution Buffer B: Lot number 270-2718, lot number: GA10430, Exp 2/29/2012.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: MD, MI, MN, NY, OH, SC, VA and WI.
  • Description du dispositif
    VARIANT II TURBO Link Hemoglobin A1c Program Reorder Pack. || Calibrator/Diluent Set. || IVD. || Kit components: || Elution Buffer A, 2 x 2500 mL || Elution Buffer B, 1 x 2100 mL || Wash/Diluent Solution, 1 x 2500 mL || Cartridge Set, 2 Cation exchange Analytical Cartridges, 4 Cation Guard Cartridges; || CD-ROM - || Calibration/Diluent Set, 2 levels, 2 vials each of lyophilized human red blood cell hemolysate with preservative, 1 bottle of diluent, 100 mL, deionized water || Whole Blood Primer, 6 x 1 mL || Sample Vials, 2 x 100 || Instruction Manual. || Bio-Rad Laboratories Inc. Hercules, CA 94547 || Intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (H LPC).
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Bio-Rad Laboratories, Inc., 4000 Alfred Nobel Drive, Hercules CA 94547-1803
  • Société-mère du fabricant (2017)
  • Source
    USFDA