Device Recall DiaSorin Lp(a) diluent

  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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
  • 제품 설명
    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

제조사

  • 제조사 주소
    Diasorin Inc., 1951 Northwestern Ave S, Stillwater MN 55082-7536
  • 제조사 모회사 (2017)
  • Source
    USFDA