Events

Recall of Device Recall CELLDYN 1700CS

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
    53212
  • Event Risk Class
    Class 2
  • Event Number
    Z-1629-2010
  • Event Initiated Date
    2009-06-08
  • Event Date Posted
    2010-05-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84993
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    multiparameter hematology analyzer - Product Code gkz
  • Reason
    Use of syringe ln 04h36-01 with the die-cast syringe drive may result in leakage, leading to delay in reporting patient results.
  • Action
    A Product Correction Letter and Customer Rely Form were sent to all currently active Cell -Dyn Sapphire customer. New customers are being notified with a Product Information Letter. For questions regarding this information, U,S, customers should call Customer Support at 1-877-4ABBOTT. Customers outside the U.S., please contact your local hematology customer support representative.

Device

Device Recall CELLDYN 1700CS
  • Model / Serial
    Control Number 42285V 42283V 42261V 42262V 42279V 42184V96 40655V96 42268V 42284V 42267V 40437V96
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: United States, Canada, Mexico, Anguilla, Australia, Argentina, Belize, Bermuda, Brazil, China, Chile, Columbia, Costa Rica, Ecuador, El Salvador, Germany, Guatemala, Haiti, Honduras, Hong Kong, Japan, Paraguay, Peru, Puerto Rico, Singapore, South Korea, Uruguay, and Venezuela.
  • Product Description
    CELL-DYNE 1700CS (Closed Sampler), list numbers 03H57-01, 03H57-03, manufactured by Abbott Hematology, Santa Clara, CA
  • Manufacturer
    Abbott Laboratories

Manufacturer

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