Events

Recall of Device Recall CELLDYN 4000

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
    37450
  • Event Risk Class
    Class 2
  • Event Number
    Z-0639-2007
  • Event Initiated Date
    2004-05-12
  • Event Date Posted
    2007-03-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-05-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50570
  • 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
    Reagent - Product Code GIF
  • Reason
    Incorrect test results-test results 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
    On May 12, 2004, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be disposed.

Device

Device Recall CELLDYN 4000
  • Model / Serial
    Lot Numbers:  14454I2, 14455I2,  14456I2,  14457I2,  15611I2
  • Product Classification
    Hematology and Pathology Devices
  • 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
    Abbott Laboratories

Manufacturer

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