Device Recall Roche/Hitachi Modular E Module GMMI clinical chemistry analyzer

  • 모델명 / 제조번호(시리얼번호)
    All units with software version 08-02.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution --- including states of Florida, Georgia, Indiana, New Jersey and North Carolina.
  • 제품 설명
    Roche/Hitachi Modular Analytics System, Modular E Module GMMI immunoassay analyzer; Catalog numbers 04998642001 and 03617505001. || Intended for qualitative and quantitative in vitro determinations using a wide variety of tests. || Roche Diagnostics Corporation, 9115 Hague Road, Indianapolis, IN, 46250
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46250-0416
  • Source
    USFDA