Z-0637-04

Cytomics RXP Software, Version 1.0, Part Numbers: 175488 6418489 175260 175261 175262 175263 175264 175265

Name: Z-0637-04 Cytomics RXP Software, Version 1.0, Part Numbers: 175488 6418489 175260 175261 175262 175263 175264 175265
Creator: Beckman Coulter Inc
Published: 2004-02-13
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2004-02-13 / Terminated / root cause: software

FDA source

Beckman Coulter Inc began a recall of Cytomics RXP Software, Version 1.0, Part Numbers: 175488 6418489 175260 175261 175262 175263 175264 175265 on 2004-02-13. The reason FDA records is "Software anomaly. Sample ID and the Run Date may become fixed within a header on the FlowPAGE printout. All samples subsequently run, with results printed using the FlowPAGE print format, will have the fixed Sample ID...". 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-0637-04
Status: Terminated
Initiated: 2004-02-13
Posted: 2004-07-20
Terminated: 2012-05-08
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Cytomics RXP Software, Version 1.0, Part Numbers: 175488 6418489 175260 175261 175262 175263 175264 175265
Product code: GKL Counter, Cell, Automated (Particle Counter)
Reason for recall: Software anomaly. Sample ID and the Run Date may become fixed within a header on the FlowPAGE printout. All samples subsequently run, with results printed using the FlowPAGE print format, will have the fixed Sample ID and Run Date, rather than the correct Sample ID and Run Date.
Root cause tag: software
FDA root cause: Other
Action: Firm sent modified operating instructions to users on 13 February 2004.
Quantity in commerce: 390
Distribution: Nationwide and Canada
Product codes and lots: Version 1.0

Product code GKL

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)