Device Recall directCheck

  • 모델명 / 제조번호(시리얼번호)
    Catalog number: DCJLR-N; Lot number: M9DNL055, exp. 9/2010
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide and one customer in Belgium.
  • 제품 설명
    International Technidyne Corporation (ITC) directCheck Whole Blood Quality Controls Plasma, Coagulation Control. Catalog number: DCJLR-N; in vitro diagnostic || 15 vials || For performance of Level 1 quality control ACT-LR test cuvettes on the Hemochron Microcoagulation Systems.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    International Technidyne Corp., 6-8 Olsen Avenue, Edison NJ 08820-2419
  • 제조사 모회사 (2017)
  • Source
    USFDA