Device Recall CellDyn 3500 System with Immature Reticulocyte Fraction (IRF)

  • 모델명 / 제조번호(시리얼번호)
    List Number 91350-01; lot numbers: 31222P, 32091P Refurbished list number: 91350-03; lot number: 32159P96
  • 의료기기 분류등급
  • 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 3500SL Analyzer and CELL-DYN 3500SL Analyzer (refurb). || Abbott Diagnostics Division, Santa Clara, CA 05054 || Designed for in vitro diagnostic use in clinical laboratories.
  • Manufacturer
  • 1 Event

제조사

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