Devices

Device Recall Abbott CellDyn 3200 System

  • 모델명 / 제조번호(시리얼번호)
    List Number 04H60-01; lot number: 61401AF, 61686AF, 61705AF, 62201AF, 62634AF, and 62469AF; Refurbished list number: 04H60-03; lot numbers: 62418AF96, and 60311AF96.
  • 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 3200SL Analyzer and CELL-DYN 3200SL 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 Abbott CellDyn 3200 System
  • 모델명 / 제조번호(시리얼번호)
    List Number 04H59-01; lot number: 30406AH; Refurbished list number: 04H59-03; lot numbers: 30687AH96, 30688AH96, 30689AH96, 30690AH96, and 30448AH96.
  • 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 3200CS Analyzer and CELL-DYN 3200CS Analyzer (refurb). || Abbott Diagnostics Division, Santa Clara, CA 05054 || Designed for in vitro diagnostic use in clinical laboratories.
  • Manufacturer
    Abbott Laboratories