FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc: 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
- Recall number
- Z-1259-06
- Recalling firm
- Beckman Coulter Inc
- 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
- Status
- Terminated
- Initiated
- 2006-05-22
- Posted
- 2006-07-26
- Terminated
- 2012-04-26
- Reason
- 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.
- Root 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
- 424
- Distribution
- Nationwide and Canada
- Lot, serial or model codes
- Software Versions 2.0 and 2.1
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXG
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28