Events

Recall of Device Recall CELLDYN Emerald Hematology Analyzer

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
    52964
  • Event Risk Class
    Class 2
  • Event Number
    Z-0065-2010
  • Event Initiated Date
    2009-07-16
  • Event Date Posted
    2009-10-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84354
  • 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
    Software bug. the cell-dyn emerald wbc l1 flag is configured incorrectly. the flag is not generated according to system requirements.
  • Action
    Abbott Diagnostics issued a "Product Correction" notice dated July 16, 2009 describing the affected product. The notice was sent to all currently active users and included a customer reply form, a software update and installation instructions. For further information, contact Abbott Customer Support at 1-877-4ABBOTT. Customers outside the U.S. should contact your local hematology customer support representative.

Device

Device Recall CELLDYN Emerald Hematology Analyzer
  • Model / Serial
    All Serial Numbers under Product Listing Number: 09H39-01.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States (AL, AR, AZ, CA, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI and WV), Canada, Germany, Puerto Rico, Singapore, and South Korea.
  • Product Description
    CELL-DYN Emerald Hematology Analyzer, model number 09H39-01. Distributed by Abbott Diagnostics Division, Santa Clara, CA. || Automated analyzer intended for in-vitro diagnostic use in the clinical laboratory.
  • Manufacturer
    Abbott Laboratories

Manufacturer

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