Device Recall IMMULITE/IMMULITE 1000 Progesterone (LKPG 1,5)

  • Model / Serial
    Lot Numbers: 318, 319, 320, 321, 322, 323, 324, 325, 326, and 327.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of Argentina, Aruba, Australia, Austria, Bangladesh, Bolivia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Cyprus, Czech Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Mexico, Netherlands, Nicaragua, Pakistan, Peru, Philippines, Poland, Portugal, Puerto Rico, Republic of Panama, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, United Arab Emirates (UAE), United Kingdom, Uruguay, and Venezuela.
  • Product Description
    IMMULITE/IMMULITE 1000 Progesterone (LKPG 1,5) || For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers - for the quantitative measurement of progesterone in serum, as an aid in the diagnosis and treatment of disorders of the ovaries or placenta.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Siemens Medical Solutions Diagnostics, 1717 Deerfield Rd, Deerfield IL 60015-3900
  • Manufacturer Parent Company (2017)
  • Source
    USFDA