Beckman Coulter Inc Cytomics FC 500 Flow Cytometry System with CXP Software, Part Numbers: 626553, Version 2.2 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cytomics FC 500 Flow Cytometry System with CXP Software, Part Numbers: 626553, Version 2.2
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
Part Numbers 626553, Version 2.2
Products Sold
Part Numbers 626553, Version 2.2
Beckman Coulter Inc is recalling Cytomics FC 500 Flow Cytometry System with CXP Software, Part Numbers: 626553, Version 2.2 due to Software error: The recall was initiated after Beckman Coulter identified that the CXP User documentation does not adequately characterize the use of . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software error: The recall was initiated after Beckman Coulter identified that the CXP User documentation does not adequately characterize the use of the Live Gate feature. The primary use of a Live Gate is for the international removal of unwanted events, such as debris. The data outside of the Live Gate will not be stored to the final listmode file, this reducing the data set size. The softwa
Recommended Action
Per FDA guidance
The customer notifications were initiated by Beckman Coulter on July 23, 2007 when a Product Corrective Action (PCA) was mailed via US Postal Service to all affected customers. The PCA informed the customers that the user documentation does not adequately characterize the use of the Live Gate feature. The letter provides the customer with explanation of Live Gate and actions to be taken. For further information, please contact Beckman Coulter, Inc. by telephone at 714-993-5321.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026