Z-2028-2008

Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - SW Kit, CXP Analyis SW V2.2, 3...

Name: Z-2028-2008 Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - SW Kit, CXP Analyis SW V2.2, 3...
Creator: Beckman Coulter Inc
Published: 2007-05-04
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2007-05-04 / Terminated / root cause: software

FDA source

Beckman Coulter Inc began a recall of Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - SW Kit, CXP Analyis SW V2.2, 3 User, Automated differential cell counter; Part... on 2007-05-04. The reason FDA records is "Incorrect Display: In certain modes, the protocol will not initially display the correct data in some plots. In addition, when running EWL files, any edited SampleID1 is not automatically updated in all tubes in 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-2028-2008
Status: Terminated
Initiated: 2007-05-04
Posted: 2008-07-11
Terminated: 2011-07-11
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - SW Kit, CXP Analyis SW V2.2, 3 User, Automated differential cell counter; Part Number 774199; Beckman Coulter; Miami, FL 33196.
Product code: GKZ Counter, Differential Cell
Reason for recall: Incorrect Display: In certain modes, the protocol will not initially display the correct data in some plots. In addition, when running EWL files, any edited SampleID1 is not automatically updated in all tubes in the panel.
Root cause tag: software
FDA root cause: Software design
Action: Consignees were notified of this safety recall by an Urgent Product Corrective Action letter sent on 5/3/07. The letter provided instructions on how to ensure correct data acquisition. Users were requested to return a response form acknowledging receipt of the letter. For additional information contact 1-800-526-7694.
Quantity in commerce: 445 units in the US; 56 units in Canada
Distribution: Worldwide Distribution including USA and country of Canada.
Product codes and lots: Part Number 774199

Product code GKZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)