Device Recall IMMULITE 2000 Systems T3F (Free T3)

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers 737, 738, 739, 740, 741, 742, 743
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) and the countries of Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bulgaria, Bosnia-Herzegovina, Brazil, Belarus, Canary Islands, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Great Britain, Greece, Guatemala, Honduras, Hungary, Iceland, India, Indonesia, Ireland, Israel, Iran, Italy, Jordan, Republic of South Korea, Kuwait, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Macedonia, Mexico, Malaysia, Malta, Nepal, Netherlands, Norway, Panama, Peru, Philippines, Pakistan, Paraguay, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Sri Lanka, South Africa, Switzerland, Turkey, Thailand, Taiwan, Uruguay, Usbekistan, Venezuela, Vietnam, and United Arab Emirates.
  • 제품 설명
    T3F, Free T3 Assay, REF/Catalog Number L2KF32 (200 tests), Siemens Material Number (SMN) 10381675, and REF/Catalog Number L2KF36 (600 Tests), SMN 10381682; an IVD Immunoassay kit for use with the IMMULITE 2000/IMMULITE 200 XPi Analyzers --- Origin: UK Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL UK. || For the quantitative measurement of Free T3 in serum, as an aid in the clinical assessment of thyroid status.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Siemens Healthcare Diagnostics, 511 Benedict Ave, Tarrytown NY 10591-5005
  • Source
    USFDA