Z-0266-05

CXP software for Cytomics FC500 Cytometer

Name: Z-0266-05 CXP software for Cytomics FC500 Cytometer
Creator: Beckman Coulter Inc
Published: 2004-11-02
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2004-11-02 / Terminated / root cause: software

FDA source

Beckman Coulter Inc began a recall of CXP software for Cytomics FC500 Cytometer on 2004-11-02. The reason FDA records is "Incorrect sample identification can be displayed and printed on the Runtime Panel Report due to a software defect". 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-0266-05
Status: Terminated
Initiated: 2004-11-02
Posted: 2004-11-30
Terminated: 2012-05-08
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: CXP software for Cytomics FC500 Cytometer
Product code: GKZ Counter, Differential Cell
Reason for recall: Incorrect sample identification can be displayed and printed on the Runtime Panel Report due to a software defect.
Root cause tag: software
FDA root cause: Other
Action: The Product Corrective Action Customer Letter which includes Modified Operating Instructions was sent to US and Canadian customers the week of November 8, 2004 via US Mail.
Quantity in commerce: 167
Distribution: Nationwide and Canada
Product codes and lots: Versions 1.0, 1.1, and 2.0

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)