Events

Recall of Device Recall CELLDyn Ruby 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
    50478
  • Event Risk Class
    Class 2
  • Event Number
    Z-1064-2009
  • Event Initiated Date
    2008-11-17
  • Event Date Posted
    2009-04-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-11-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75463
  • 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
    Differential Cell Counter - Product Code GKZ
  • Reason
    Carryover failures in software revisions 1.0ml and 2.0ml result in elevated plt background count.
  • Action
    Recall initiated on 11/17/2008. A Product Correction letter and customer reply form is sent to all currently active CELL-DYN Ruby customers. The customers are asked to keep the communication with their CELL-DYN Ruby System Operator's Manual and to note that the information listed in the table replaces the carryover specification provided in all applications of the manual. Questions from customers in the US should be directed to Customer Support at 1-877-4ABBOTT. Customers outside the US should contact their local hematology customer support representative.

Device

Device Recall CELLDyn Ruby Hematology Analyzer
  • Model / Serial
    Serial No. 34001BG - 34965BG
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    CELL-Dyn Ruby Hematology Analyzer, List Number 08H67-01 || The CELL-DYN Ruby is a multi-parameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The instrument has two modes of operation: the Autoloader mode that aspirates samples from closed collection tubes and the Open Tube mode that aspirates samples from open collection tubes.
  • Manufacturer
    Abbott Laboratories

Manufacturer

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