Device Recall CELLDYN 4000

  • Model / Serial
    Lot Numbers:  14454I2, 14455I2,  14456I2,  14457I2,  15611I2
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Class II- Worldwide Distribution-USA including the states of AL, CA, CO, CT, DE, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OR, PA, SC, TN, TX, VA, WA, WI, and WV and countries of Argentina, Brazil, Hong Kong, Japan, Malaysia, Singapore, Taiwan, and Thailand.
  • Product Description
    CELL-DYN 4000 Diluent/Sheath Reagent, || List Number 01H73-01, Distributed and Manufactured by: Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA
  • Manufacturer
  • 1 Event

Manufacturer

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

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    List Number 07H95-01, manufactured between June 18 to November 11, 2009.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including states of: CA, CO, FL, GA, KY, NC, NJ, NY, OR, VA, and WV; and countries including: Argentina, Australia, Canada, Germany and Japan.
  • Product Description
    CELL-DYN 4000 Vent Head Spring Assembly, a component of the CELL-DYN 4000 Automated Hematology Analyzer, List Number 07H95-01, manufactured by Abbott Diagnostics Division, Santa Clara, CA || Medical device component. The CELL-DYN 4000 System is a multiparameter automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The vent head spring assembly is used in the auto-sampling mechanism on the CELL-DYN 4000.
  • Manufacturer
  • Model / Serial
    Manufacturing date codes between 01.Jan.2010 and 23.Jun.2010
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: Thoroughout the US, and in the countries of Argentina, Canada, Germany, Hong Kong, Japan, and Singapore.
  • Product Description
    CELL-DYN Vent Needle used on the CELL-DYN Sapphire and CELL-DYN 4000 Hematology Analyzers; || CELL-DYN Sapphire Vent Head Assembly, List Number: 08H53-02, || CELL-DYN Sapphire Accessory Kit, List Number: 08H03-01, || CELL-DYN 4000 Vent Needle, List Number: 02H61-01, || CELL-DYN 4000 Accessory Kit, List Number: 01H20-01, || CELL-DYN 4000 Vent Needle Upgrade Kit, List Number: 9130576, || CELL-DYN 4000 Vent Head Assembly, List Number: 8921187101, || CELL-DYN 4000 Sample Processor Assembly, List Number: 8921198201; || Product is manufactured and distributed by Abbott Diagnostics Division, Santa Clara, CA
  • Manufacturer