Events

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
    Recall
  • Event ID
    45446
  • Event Risk Class
    Class 2
  • Event Number
    Z-0301-2008
  • Event Initiated Date
    2007-07-25
  • Event Date Posted
    2008-01-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-11-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65478
  • 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
    Hematology Analyzer Syringe - Product Code GKZ
  • Reason
    Syringe failure: insufficient lubrication of the plunger tip may cause syringes to fail at installation or shortly thereafter.
  • Action
    This Recall was initiated 07/24/07 via a Product Recall letter-Immediate Action Required-instructing users to discontinue use and destroy any units under recall. Replacements may be obtained by contacting the local Customer Support Center at 1-877-4Abbott

Device

Device Recall CELLDYN
  • Model / Serial
    Package Dates (printed on syringe label); 08 May 2007 to 25 June 2007
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA including states of AR, AZ, CA, CT, FL, GA, ID, KY, LA, MD, MI, NC, ND, NV, NY, OH, OK, PA, SC, TX, UT, VA, and W I (4 distributors and 50 consignees)and countries of Australia, Brazil, Chile, Germany, and Hong Kong.
  • Product Description
    Abbott Diagnostics CELL-DYN Sapphire Hemoglobin Reagent Analyzer Syringes, List Number 08H49-02, Abbott Laboratories, Abbott Park, IL (the syringe is packaged in a white box and sealed with a label wrapped around the center of the box-The main analyzer list number is 08H00-01, )
  • Manufacturer
    Abbott Laboratories

Manufacturer

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