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

  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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
  • 1 Event

Fabricant

  • Adresse du fabricant
    Abbott Laboratories, 5440 Patrick Henry Dr, Santa Clara CA 95054-1113
  • Source
    USFDA

Un dispositif médical avec un nom similaire

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  • Modèle / numéro de série
    List Number 02H30-01; lot number 20071AN; Refurbished list number: 02H030-03; lot numbers 20478AN96, 20390AN96, and 20421AN96.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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