Device Recall Sysmex XE2100C Automated Hematology System

  • Model / Serial
    catalog ##053-2311-4, all serial numbers
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including Puerto Rico.
  • Product Description
    Sysmex XE-2100C Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #053-2311-4 || The Sysmex XE-2100C is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Sysmex America, Inc., 1 Nelson C White Pkwy, Mundelein IL 60060-9528
  • Manufacturer Parent Company (2017)
  • Source
    USFDA