Z-0420-2007

CXP Analysis Software, Versions 2.0 & 2.1: Part #722396 CXP Analysis Software Kit V2.1, Single User; Part...

Name: Z-0420-2007 CXP Analysis Software, Versions 2.0 & 2.1: Part #722396 CXP Analysis Software Kit V2.1, Single User; Part...
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 CXP Analysis Software, Versions 2.0 & 2.1: Part #722396 CXP Analysis Software Kit V2.1, Single User; Part #722395 CXP Analysis Software Kit V2.1, Single User... 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-0420-2007
Status: Terminated
Initiated: 2006-08-29
Posted: 2007-02-08
Terminated: 2012-04-19
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: CXP Analysis Software, Versions 2.0 & 2.1: Part #722396 CXP Analysis Software Kit V2.1, Single User; Part #722395 CXP Analysis Software Kit V2.1, Single User Upgrade; Part #722397 CXP Analysis Software Kit V2.1, 3 User Pack; Part #722398 CXP Analysis Software Kit V2.1, 5 User Pack; Part #722399 CXP Analysis Software Kit V2. 1, 15 User Pack; Part # 722593 CXP Analysis Software Kit V2.1, 5 Network User Pack Part #722594 CXP Analysis Software Kit V2.1, 10 Network User Pack; Part #722595 CXP Analysis Software Kit V2.1, 15 Network User Pack; Part #629640 CXP Analysis Software Kit V2.0, Single User; Part #629639 CXP Analysis Software Kit V2.0, Single User Upgrade; Part #629641 CXP Analysis Software Kit V2.0, 3 User Pack; Part #629642 CXP Analysis Software Kit V2.0, 5 User Pack; Part #629643 CXP Analysis Software Kit V2.0, 15 User Pack; Part #629644 CXP Analysis Software Kit V2.0, 5 Network User Pack; Part #629645 CXP Analysis Software Kit V2.0, 10 Network User Pack; Part #629646 CXP Analysis Software Kit V2.0, 15 Network User Pack. 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: 200 units nationwide
Distribution: Nationwide & Canada
Product codes and lots: Part Numbers: 722396, 722395, 722397, 722398, 722399, 722593, 722594, 722595, 629640, 629639, 629641, 629642, 629643, 629644, 629645, 629646. 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)