Device Recall DiaSorin Lp(a) diluent

  • Modèle / numéro de série
    Lp(a) Diluent - 60 mL bottles Catalog #23817, Lot #s 238017-01 & 238017-03; catalog # 95046B, Lot # 238017-02. DiaSorin Lp(a) Antibody Reagent Kits Catalog # 86084, Lot #s 1144332, 114432A,113656, 113656A, and 113656B
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    KC, MO, CA, IN, HI, GA, TX, MN, ME, AZ, FL, VA, MI, NJ, NC, NY, CO, WI, MS, BRUSSELS, GREECE, SWEDEN, ENGLAND, SPAIN, CANADA & SWITZERLAND
  • Description du dispositif
    Lp(a) Diluent packaged into 60 mL bottles, Catalog #23817, Lot #s 238017-01 & 238017-03; 480 mL bulk catalog # 95046B, Lot # 238017-02. 60 mL bottles can be part of DiaSorin Lp(a) Antibody Reagent Kits Catalog # 86084, Lot #s 1144332, 114432A,13656, 113656A, and 113656B for use in DiaSorin Antibody Reagent Set for Lp(a) SPQ Test System .
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Diasorin Inc., 1951 Northwestern Ave S, Stillwater MN 55082-7536
  • Société-mère du fabricant (2017)
  • Source
    USFDA