FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc: Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - SW Kit, CXP Analyis SW V2.2, 5 User, Automated differential cell counter; Part Number 774200; Beckman Coulter; Miami, FL 33196.
- Recall number
- Z-2029-2008
- Recalling firm
- Beckman Coulter Inc
- Product
- Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - SW Kit, CXP Analyis SW V2.2, 5 User, Automated differential cell counter; Part Number 774200; Beckman Coulter; Miami, FL 33196.
- Status
- Terminated
- Initiated
- 2007-05-04
- Posted
- 2008-07-11
- Terminated
- 2011-07-11
- Reason
- Incorrect Display: In certain modes, the protocol will not initially display the correct data in some plots. In addition, when running EWL files, any edited SampleID1 is not automatically updated in all tubes in the panel.
- Root cause
- Software design
- Action
- Consignees were notified of this safety recall by an Urgent Product Corrective Action letter sent on 5/3/07. The letter provided instructions on how to ensure correct data acquisition. Users were requested to return a response form acknowledging receipt of the letter. For additional information contact 1-800-526-7694.
- Quantity
- 445 units in the US; 56 units in Canada
- Distribution
- Worldwide Distribution including USA and country of Canada.
- Lot, serial or model codes
- Part Number 774200
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GKZ
- 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