Device Recall IMMULITE 2000 Systems T3F (Free T3)

  • Modèle / numéro de série
    Lot Numbers 737, 738, 739, 740, 741, 742, 743
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Siemens Healthcare Diagnostics, 511 Benedict Ave, Tarrytown NY 10591-5005
  • Source
    USFDA