Z-0418-2007

Cytomics FC 500 with CXP software, Versions 2.0 & 2.1: Part #722645, Software Kit; CXP version 2.1 New User...

Name: Z-0418-2007 Cytomics FC 500 with CXP software, Versions 2.0 & 2.1: Part #722645, Software Kit; CXP version 2.1 New User...
Creator: Beckman Coulter Inc
Published: 2006-08-29
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2006-08-29 / Terminated

FDA source

Beckman Coulter Inc began a recall of Cytomics FC 500 with CXP software, Versions 2.0 & 2.1: Part #722645, Software Kit; CXP version 2.1 New User; Part #723113 Software Kit; CXP version 2.1... on 2006-08-29. The reason FDA records is "Two workflow scenarios associated with renaming regions may produce incorrect results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0418-2007
Status: Terminated
Initiated: 2006-08-29
Posted: 2007-02-08
Terminated: 2012-04-19
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Cytomics FC 500 with CXP software, Versions 2.0 & 2.1: Part #722645, Software Kit; CXP version 2.1 New User; Part #723113 Software Kit; CXP version 2.1 Upgrade; Part #629637 Software Kit; CXP version 2.0 New User; Part #629636 Software Kit; CXP version 2.0 Upgrade. The Cytomics FC 500 is a system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles.
Product code: GKZ Counter, Differential Cell
Reason for recall: Two workflow scenarios associated with renaming regions may produce incorrect results.
FDA root cause: Other
Action: A Product Corrective Action (PCA) letter was sent on the week of August 29, 2006 to all accounts that have an FC500 or have ordered CXP or MXP software to inform them that a) incorrect statistics are generated when a polygonal region with vertical re-entrant vertices is renamed using the Region Properties dialog box. b)when a region is copied from one plot to another, and then the new region is renamed, the statistics are not updated with the new region name. (Letter was sent by US mail). Letter includes immediate user preventive action to remedy both issues. A response form is included for consignees to return to recalling firm.
Quantity in commerce: 397 nationwide
Distribution: Nationwide & Canada
Product codes and lots: Part Numbers: 722645, 723113, 629637, 629636 Software, Versions 2.0 & 2.1

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)