Device Recall ABL 80 COOX SYSTEM

  • Model / Serial
    Model Number: 393-841 all serial numbers are affected.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Domestically and Worldwide: Germany, France, Spain, United Kingdom, Poland, Austria, Italy, Tokyo, Australia, and Denmark Domestically to OH
  • Product Description
    ABL 80 CO-OX SYSTEM, software versions 1.30 and 1.31 || Additional Product Codes: CEM, CGA, CGZ, GHS, GKR, GLY, JFP, JGS, JIX, JJY, JPI || The ABL 80 CO-OX SYSTEM is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL 80 CO-OX SYSTEM is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Sendx Medical Inc, 1945 Palomar Oaks Way, Carlsbad CA 92009-1307
  • Source
    USFDA