Devices

Device Recall CellDyn 3700 System with Immature Reticulocyte Fraction (IRF)

  • 모델명 / 제조번호(시리얼번호)
    List Number 02H31-01; lot numbers: 23444AK, 23445AK, 23446AK, 23448AK to 23456AK, 23461AK, 20576AK, 21408AK, 21426AK, 21515AK, 21651AK, 21694AK, 271726AK, 21955AK, 22145AK, 22229AK, 22458AK, 22732AK, 22760AK, 23198AK, 23209AK, 23210AK, 23236AK, 22881AK, 19966AK, 20880AK, 20924AK, 21051AK, 21522AK, and 22650AK. Refurbished list number: 02H31-03; lot numbers: 20074AK96, 20334AK96, 20416AK96, 20751AK96, 20985AK96, 21167AK96, 21368AK96, 21610AK96, 21753AK96, 21842AK96, 21885AK96, 21934AK96, 22142AK96. 22340AK96, 22346AK96, 22380AK96, 22501AK96, 23056AK96, 23145AK96, 23457AK96, 23458AK96, 23459AK96, 23460AK96, and 23462AK96.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- AZ, CA, FL, IA, ID, IN, MA, MI, MN, MS, ND, NY, OK, OR, SC, SD, TX, WI, WY and Germany, Singapore, Mexico, China, South Korea, Argentina, Japan, Brazil, Canada, Australia, and Chile.
  • 제품 설명
    CELL-DYN Shear Valve Assembly used on CELL-DYN 3700SL Analyzer and CELL-DYN 3700SL Analyzer (refurb). || Abbott Diagnostics Division, Santa Clara, CA 05054 || Designed for in vitro diagnostic use in clinical laboratories.
  • Manufacturer
    Abbott Laboratories
  • 1 Event

제조사

Abbott Laboratories
  • 제조사 주소
    Abbott Laboratories, 5440 Patrick Henry Dr, Santa Clara CA 95054-1113
  • Source
    USFDA

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Device Recall CellDyn 3700 System with Immature Reticulocyte Fraction (IRF)
  • 모델명 / 제조번호(시리얼번호)
    List Number 02H30-01; lot number 20071AN; Refurbished list number: 02H030-03; lot numbers 20478AN96, 20390AN96, and 20421AN96.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- AZ, CA, FL, IA, ID, IN, MA, MI, MN, MS, ND, NY, OK, OR, SC, SD, TX, WI, WY and Germany, Singapore, Mexico, China, South Korea, Argentina, Japan, Brazil, Canada, Australia, and Chile.
  • 제품 설명
    CELL-DYN Shear Valve Assembly used on CELL-DYN 3700CS Analyzer and CELL-DYN 3700CS Analyzer (refurb). || Abbott Diagnostics Division, Santa Clara, CA 05054 || Designed for in vitro diagnostic use in clinical laboratories.
  • Manufacturer
    Abbott Laboratories