Recall of Device Recall CELLDYN

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Laboratories.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Diluent/Sheath Reagent - Product Code GIF
  • Reason
    Incorrect test results-product may show a higher than expected platelet background count when used on the cell-dyn 4000 system and report patient results that are unacceptable (out-of-range).
  • Action
    Recall Letter-On 2/24/04, the firm initiated the recall and its notification explaining the reason for the recall and requesting the product be destroyed


  • Model / Serial
    Lot Numbers: 10916I2, 10917I2,  10918I2,  10919I2,  10920I2,  10921I2
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution-USA including states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, lA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, ND, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WI, and WV. and countries of Australia, Argentina, Brazil, Hong Kong, Japan, Korea, Malaysia, Singapore.
  • 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


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