Device Recall ADVIA Centaur Vitamin D Diluent 2pack

  • 모델명 / 제조번호(시리얼번호)
    Lot # 80230 Expiry Date 04 May 2012
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) and countries of: Columbia, China, Denmark, Egypt, and Hong Kong.
  • 제품 설명
    Siemens ADVIA Centaur Vitamin D Diluent 2-pack, || Reference 10494100 || in vitro diagnostic use in the quantitative determination of total || 25 (OH) vitamin D in human serum and plasma (EDTA, lithium-heparin, sodium heparin) using the ADVIA Centaur and ADVIA Centaur XP systems || The ADVIA Centaur Vitamin D Total (Vit D) assay is for in vitro diagnostic use in the quantitative determination of total 25 (OH) vitamin D in human serum and plasma (EDTA, lithium-heparin, sodium heparin) using the ADVIA Centaur and ADVIA Centaur XP systems. The ADVIA Centaur Vit Assay is intended as an aid in the determination of vitamin D insufficiency. The ADVIA Centaur Vitamin D Diluent 2-pack is used on board the ADVIA Centaur systems to perform automatic and system-performed dilutions fro Vitamin D assay.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc, 333 Coney St, East Walpole MA 02032-1516
  • 제조사 모회사 (2017)
  • Source
    USFDA