Z-0129-2009

Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.2, Part Number: 626553. This product is...

Name: Z-0129-2009 Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.2, Part Number: 626553. This product is...
Creator: Beckman Coulter Inc
Published: 2007-10-11
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2007-10-11 / Terminated / root cause: software

FDA source

Beckman Coulter Inc began a recall of Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.2, Part Number: 626553. This product is used for the qualitative and quantitative measurement... on 2007-10-11. The reason FDA records is "Software error: This field action was initiated after Beckman Coulter determined that the CXP software does not refresh the dataset automatically under certain circumstances. The User documentation does not clearly...". 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-0129-2009
Status: Terminated
Initiated: 2007-10-11
Posted: 2009-01-13
Terminated: 2009-01-13
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.2, Part Number: 626553. This product is used for the qualitative and quantitative measurement of biological and physical properties of cells and other particles. These properties are measured when the cells pass through one or two laser beams in single-file.
Product code: GKZ Counter, Differential Cell
Reason for recall: Software error: This field action was initiated after Beckman Coulter determined that the CXP software does not refresh the dataset automatically under certain circumstances. The User documentation does not clearly state that the user should refresh the dataset after changes are made.
Root cause tag: software
FDA root cause: Software design
Action: Software error: A Product corrective Action (PCA) letter was mailed via US Postal Service on October 17, 2007 to all Cytomics FC 500 Flow Cytometry System with CXP Software accounts. This letter was entitled "URGENT: PRODUCT CORRECTIVE ACTION." Customers were informed that the user documentation does not clearly state that the user should refresh the dataset after changes are made. The letters provide the customers with an explanation and action to be taken whenever a protocol containing data is modified by making changes to cytosettings, regions or gates. Customer were instructed to review all data plots and results before reporting results out. any uncharacteristic patterns in the data or unexpected results must be verified by running Quality Control and if necessary, preparing new samples. In addition, customer were instructed to please share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. Also they were asked to complete and return the an attached Customer Response Form within ten days. Customers with questions or concerns regarding the notification, could call Beckman Coulter Customer Service at 1-800-526-7694 in the United States or Canada. Outside the US and Canada, they were to contact their local Beckman Coulter Representative.
Quantity in commerce: 594 Worldwide: 518 in the United States and 76 in Canada
Distribution: Globally - United States and Canada
Product codes and lots: Part Number: 626553; Software 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)