Device Recall Ultrasonic Transducer Kits

  • 모델명 / 제조번호(시리얼번호)
    Access 2 Immunoassay Systems, Catalog Number: 81600N. UniCel DxI 600 Access Immunoassay Systems, Catalog Numbers: A30260 and A71460. UniCel DxI 800 Access Immunoassay Systems, Catalog Numbers: 973100 and A71456. UniCel DxC 600i SYNCHRON Access Clinical Systems, Catalog Number: A25640.  Catalog numbers for these systems are included in the respective DxI 600 and DxI 800 model numbers: UniCel DxC  660i SYNCHRON Access Clinical Systems, UniCel DxC 680i SYNCHRON Access Clinical Systems, UniCel DxC 860i SYNCHRON Access Clinical Systems, UniCel DxC 880i SYNCHRON Access Clinical Systems.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution and USA Nationwide - and the countries of Australia, Canada, China, France, Hong Kong, Italy, Japan, Mexico, Portugal, Spain, Switzerland, Taiwan,and Turkey.
  • 제품 설명
    Ultrasonic Transducer Kits || For use with the Access Family of Immunoassay Systems*. || *The Access Family of Immunoassay Systems includes the Access 2, UniCel DxI 800 and UniCel DxI 600, || UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i || systems.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • 제조사 모회사 (2017)
  • Source
    USFDA