Z-0380-06

Cytomics FC500 with CXP Software

Name: Z-0380-06 Cytomics FC500 with CXP Software
Creator: Beckman Coulter Inc
Published: 2005-11-23
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2005-11-23 / Terminated / root cause: software

FDA source

Beckman Coulter Inc began a recall of Cytomics FC500 with CXP Software on 2005-11-23. The reason FDA records is "Under certain conditions an incorrect Tube ID (Barcode) can be displayed and printed on the Runtime Panel Report in CXP Cytometer Software Version 2.0". 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-0380-06
Status: Terminated
Initiated: 2005-11-23
Posted: 2006-01-11
Terminated: 2012-01-26
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Cytomics FC500 with CXP Software
Product code: JJF Analyzer, Chemistry, Micro, For Clinical Use
Reason for recall: Under certain conditions an incorrect Tube ID (Barcode) can be displayed and printed on the Runtime Panel Report in CXP Cytometer Software Version 2.0
Root cause tag: software
FDA root cause: Software change control
Action: A Product Corrective Action letter will be mailed the week of Nov 28, 2005 to all FC500 wi CXP Software customers. Each user will be contacted initially and then once more (if needed) in order to determine the rate of response from the Response form provided.
Quantity in commerce: 179
Distribution: Nationwide and Canada
Product codes and lots: Part Numbers 629636 629637

Product code JJF

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)