Device Recall IMMULITE 2000/2000 XPi Intact Parathyroid Hormone (IPTH)

  • Model / Serial
    Lot Number 320, exp. date 2016/11/30;  UDI #s: 0063041496191032020161130 and 0063041496192732020161130
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide) and countries of: Canada, China, Chile, Mexico, Australia, Austria, Bangladesh, Belgium, Bosnia Herzeg, Brazil, Bulgaria, Peru, Colombia, Ecuador, Bolivia, Costa Rica, Honduras, Croatia, Czech Republic, Denmark, Egypt, Estonia, France, Algeria, Greece, Guatemala, Hungary, India, Ireland, Israel, Italy, Japan, Kazakhstan, Latvia, Lebanon, Netherlands, Norway, Pakistan, Panama, Paraguay, Poland, Portugal, Republic Korea, Romania, Russian Fed., Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, Jordan, U.A.E., United Kingdom and Uruguay.
  • Product Description
    SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone) || Test Code iPTH, REF/Catalog Number L2KPP2, Siemens Material Number (SMN) 10381441 and REF/Catalog Number L2KPP6, SMN 10381442; IVD --- Made in UK -- Siemens healthcare Diagnostics Products Ltd. Glyn Rhonwy, Llanberis, Gwynedd, LL55 4EL UK || For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers - for the quantitative measurement of intact parathyroid hormone (parathyrin, PTH) in EDTA plasma and serum, as an aid in the differential diagnosis of hypercalcemia and hypocalcemia.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
  • Manufacturer Parent Company (2017)
  • Source
    USFDA