Events

Recall of Device Recall Abbott Diagnostics CELLDYN Diluent/Sheath Reagent

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
    37234
  • Event Risk Class
    Class 3
  • Event Number
    Z-0565-2007
  • Event Initiated Date
    2006-12-22
  • Event Date Posted
    2007-03-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-11-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50158
  • 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
    in vitro diagnostic - Product Code GIF
  • Reason
    Results for tests of rbc, mcv, rdw, mpv and plt may be falsely elevated or falsely decreased when the cell dyn diluent/sheath reagent is used with cell-dyn 4000, ruby and sapphire systems.
  • Action
    Recall initated 12/22/2006. Product letters were sent to consignees, as well as a customer reply form. The letters were sent with customer reply forms. Responses will be tracked via the response forms included with letters.

Device

Device Recall Abbott Diagnostics CELLDYN Diluent/Sheath Reagent
  • Model / Serial
    Lot Number 42063I2, List Number 01H73-01
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide, including California and Nevada. An Abbott Laboratories facility in Hong Kong.
  • Product Description
    CELL-DYN Diluent/Sheath Reagent, for use with CELL-DYN Ruby, Sapphire and 4000 systems. List #01H73-01. Packaged in 20 Liter cubitainers.
  • Manufacturer
    Abbott Laboratories

Manufacturer

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