Recall of Device Recall CELLDYN 3/4/8 Assay reagents for Sapphire

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
    Counter, Differential Cell - Product Code GKZ
  • Reason
    T-cell test results and the respective absolute counts for the cell-dyn sapphire instrument using cd3/4/8 reagents can be overestimated by as much as 13%.
  • Action
    The firm has sent notification letters dated Dec. 16, 2005 to all consignees requesting discontinuing of use, destruction of CD3/4/8 reagent if the lab does not plan to run on a CELL-DYN 4000 system.


  • Model / Serial
    List Number: 07H22-01, lot numbers: 16328 and 29401
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide and Canada, Venezuela, Germany, Hong Kong, Japan, Mexico and Singapore.
  • Product Description
    CELL-DYN CD 3/4/8 Assay Reagents for Sapphire Hematology Analyzer
  • Manufacturer


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