Device Recall Dimension Vista beta2Microglobulin Flex Reagent Cartridge (B2MIC)

  • 모델명 / 제조번호(시리얼번호)
    Lot Number:15037MA; ExpDate: 2016-07-14 Lot # 15175MA; ExpDate: 2015-11-17; Lot # 15204MA; Expdate: 2017-01-13;  Lot #15246MA; expdate: 2017-02-26 Lot # 15267MA; expdate: 2017-02-26
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution in the states of TN, AZ, CT, Fl, CA, NY and WI
  • 제품 설명
    Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC); || Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B¿2-Microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista System. Measurements of B¿2-Microglobulin aid in the diagnosis of active rheumatoid arthritis and kidney disease.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • 제조사 모회사 (2017)
  • Source
    USFDA