Devices

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

  • Model / Serial
    List Number 02H30-01; lot number 20071AN; Refurbished list number: 02H030-03; lot numbers 20478AN96, 20390AN96, and 20421AN96.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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
  • 1 Event

Manufacturer

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

One device with a similar name

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Device Recall CellDyn 3700 System with Immature Reticulocyte Fraction (IRF)
  • Model / Serial
    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.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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