Z-0455-2009

Cytomics FC 500 Flow Cytometry System with CXP Software, Part Numbers: 626553, Version 2.2

Name: Z-0455-2009 Cytomics FC 500 Flow Cytometry System with CXP Software, Part Numbers: 626553, Version 2.2
Creator: Beckman Coulter Inc
Published: 2007-08-01
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2007-08-01 / Terminated / root cause: software

FDA source

Beckman Coulter Inc began a recall of Cytomics FC 500 Flow Cytometry System with CXP Software, Part Numbers: 626553, Version 2.2 on 2007-08-01. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0455-2009
Status: Terminated
Initiated: 2007-08-01
Posted: 2009-01-07
Terminated: 2009-01-13
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Cytomics FC 500 Flow Cytometry System with CXP Software, Part Numbers: 626553, Version 2.2
Product code: GKZ Counter, Differential Cell
Reason for recall: 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
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 565
Distribution: Globally to the United States and Canada.
Product codes and lots: Part Numbers 626553, Version 2.2

Product code GKZ

K030828Class IITetracxp System (Software and System Guide)Beckman Coulter, Inc. / cleared 2003-05-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)