Class 2 Device Recall Beckman Coulter Cytomics FC 500 Flow Cytometry System

• Date Initiated by Firm: May 22, 2006
• Date Posted: July 26, 2006
• Recall Status: Terminated on April 26, 2012
• Recall Number: Z-1259-06
• Recall Event ID: 35643
• Product Classification: Flow Cytometry System - Product Code LXG
• Product: Cytomics FC 500 Flow Cytometry System Part Numbers 626553 (TN; FC500 with UPS), 6605627 (TN; 5 CLR, FC500 (100V)), 6605628 (TN; 5 CLR, FC500 (120V)) , 6605629 (TN; 5 CLR, FC500 (220V)), 6605630 (TN; 5 CLR, FC500 (240V)) with CXP Software Versions 2.0 and 2.1
• Code Information: Software Versions 2.0 and 2.1
• Recalling Firm/ Manufacturer: Beckman Coulter Inc; 200 S Kraemer Blvd; Brea CA 92822-6208
• For Additional Information Contact: Nora Zerounian; 714-961-3634
• Manufacturer Reason for Recall: Beckman Coulter has determined that under certain conditions a system error generated during a Pause and Rotate routine may result in a sample misidentification with a risk of reporting erroneous results.
• FDA Determined Cause: Other
• Action: A Product Corrective Action letter was sent via US mail the week of May 22, 2006 to all FC500 customers. They were informed that under certain conditions a system error generated during a Pause and Rotate routine may result in a sample misidentification with a risk of reporting erroneous results. The letter includes the sequence in which the issue occurrs: 1) During the acquistion of a tube, the Pause and Rotate Button is selected. 2) A system error is generated during the Pause and Rotate routine (The error message table may be viewed by going to the CXP Help Menu, select the CXP Help Menu Item, then to Section 13.5). 3) An error message appears in the Cytometer Status, an audible alarm sounds, the run aborts, the carousel ejects, and the system automatically transitions from Verification to Run Initialization and then to Awaiting Sample 4) The Worklist is continued or a new Worklist is loaded and started. 5) After the Worklist is continued, or loaded and started, during the acquistion of a tube, the Pause and Rotate Button is selected. 6) The carousel Pauses but does not Rotate. 7) When the Start/Continue or Restart button is selected, the carousel may move to the wrong tube and aspirate sample resulting in a sample misidentification. If no system errors are generated during a Pause and Rotate routine, the system will function correctly. The letter also provides steps for immediate user preventive action if a system error is generated during the Pause and Rotate Routine to remedy the issue: 1) Exit CXP Software. 2) Power off the Cytometer using the FC OFF utility 3) Turn the Cytometer back on. 4) Recovery should be complete and the laboratory may resume normal usage of the system. Customers are asked to share the information with their laboratory staff and to retain this notification as part of their laboratory Quality System documentation and to complete and return the enclosed Fax Response Form for the firm''s records.
• Quantity in Commerce: 424
• Distribution: Nationwide and Canada
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.