Device Recall Digital Fluidics PCB

  • Model / Serial
    IMMULITE 2000: Serial Numbers M5080 to M5137; and IMMULITE 2500: Serial Numbers F0778 to F0818.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution to states including MA, NY, PA, MD, GA, FL, OH, IN, MI, IL, MO, LA, UT, AZ and CA and countries of Canada, Czech Republic, Germany, Poland, Hungary, Belgium, Russia, Republic of South Africa, Greece, Israel, Turkey, Spain, Portugal, Denmark, France, Great Britain, India, China, South Korea and Mexico.
  • Product Description
    Immulite 2000 and Immulite 2500 digital Fluidics PC Board, || Part Number 450116-0002. || Performs chemiluminescent immunoassays using serum, plasma, and/or urine for in vitro diagnostic testing.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Siemens Medical Solutions Diagnostics, 62 Flanders-Bartley Rd, Flanders NJ 07836-4715
  • Manufacturer Parent Company (2017)
  • Source
    USFDA