Device Recall Beckman Coulter UniCel DxC 880i, 860i, and 600i Systems

  • Model / Serial
    Software Part Number: A84500, A86646; Software version: 4.9.01; Serial Number <2760
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Class II Recall - USA, including the states of CA, IN, GA, NC, NY, OH, SC, and WI
  • Product Description
    UniCel DxC 880i, 860i and 600i Systems; Software Part Number: A84500, A86646; Software || version: 4.9.01 || The UniCel Synchron Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent)
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Manufacturer Parent Company (2017)
  • Source
    USFDA