Device Recall UNICEL DXC SYNCHRON SYSTEMS

  • Model / Serial
    UniCel DxC Clinical Systems with Serial Number less than 3412 (with serial numbers less than 3412, labeled behind the lower right side instrument door)  UniCel DxC 600 Part #: A10405, UniCel DxC 600 PRO Part #: A11810, UniCel DxC 600i Part #: A27318, UniCel DxC 660i Part #: A64871, UniCel DxC 680i Part #: A64903, UniCel DxC 800 Part #:A11816, UniCel DxC 800 PRO Part #: A11812, UniCel DxC 860i Part #: A64935, and UniCel DxC 880i Part #: A59102  Subsequent Product Codes: CEK, CEO, CFJ, CGA, CGX, CJW, DCK, DLZ, JFL, JFP, JGJ, JGS, JIY, JJE, JXM, LFP, CFR, CDQ, CEM, CGN, CGZ, CHL, DCK, DFT, JFP, JGS, JHI, JIY, JJE, JLW, JMG, JXM, LCD & LCP.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--United States and countries of Angola, Australia, Belgium, Bulgaria, China, Columbia, Czech Republic, Denmark, Eritrea, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Lebanon, Lithuania, Mexico, Netherlands, Reunion, Serbia, South Korea, Spain, Slovakia, Swaziland, Sweden, Switzerland, Tunisia, Turkey, Taiwan, United Arab Emirates, and the United Kingdom.
  • Product Description
    UniCel DxC Clinical Systems with Serial Number less than 3412 Including: UniCel DxC 600 Part #: A10405, || UniCel DxC 600 PRO Part #: A11810, || UniCel DxC 600i Part #: A27318, || UniCel DxC 660i Part #: A64871, || UniCel DxC 680i Part #: A64903, || UniCel DxC 800 Part #: A11816, || UniCel DxC 800 PRO Part #: A11812, || UniCel DxC 860i Part #: A64935, and || UniCel DxC 880i Part #: A59102.
  • Manufacturer
  • 1 Event

Manufacturer

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