Z-0197-2007

Cytomics FC 500 Flow Cytometry System with CXP Software Versions 2.0 & 2.1

Name: Z-0197-2007 Cytomics FC 500 Flow Cytometry System with CXP Software Versions 2.0 & 2.1
Creator: Beckman Coulter Inc
Published: 2006-07-26
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2006-07-26 / Terminated / root cause: software

FDA source

Beckman Coulter Inc began a recall of Cytomics FC 500 Flow Cytometry System with CXP Software Versions 2.0 & 2.1 on 2006-07-26. The reason FDA records is "Mis-identification-If a panel or protocol is added to an existing worklist but the tube location is not specified, the CXP Acquisition software will run the last specified tube through the remaining protocols and will...". 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-0197-2007
Status: Terminated
Initiated: 2006-07-26
Posted: 2006-11-21
Terminated: 2012-02-29
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Cytomics FC 500 Flow Cytometry System with CXP Software Versions 2.0 & 2.1
Product code: GKZ Counter, Differential Cell
Reason for recall: Mis-identification-If a panel or protocol is added to an existing worklist but the tube location is not specified, the CXP Acquisition software will run the last specified tube through the remaining protocols and will generate results and printouts of these runs leading to a Mis-Identification condition.
Root cause tag: software
FDA root cause: Other
Action: Customer letter -- A Product Corrective Action (PCA) letter was sent the week of July 24, 2006 to all accounts that have FC500 with CXP Software 2.0 and 2.1 to inform them that a potential sample misidentification may occur when running a Work list with missing tube Location(s) in Automatic MCL mode. The letter outlines actions to be taken to avoid mis-identification of patient results.
Quantity in commerce: 416 (US) + 60 (Canada)
Distribution: Nationwide and Canada
Product codes and lots: Part Numbers: 722645 Software Kit; CXP version 2.1 New User; 723113 Software Kit; CXP version 2.1 Upgrade; 629637 Software Kit; CXP version 2.0 New User; 629636 Software Kit; CXP version 2.0 Upgrade; 626553 TN; FC500 WITH UPS; 6605627 TN; 5 CLR, FC500 (IOOV); 6605628 TN; 5 CLR, FC500 (120V); 6605629 TN; 5 CLR, FC500 (220V); 6605630 TN;5 CLR, FC500 (240V)

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)