Z-0317-2007

FC 500 MPL Flow Cytometry System with MXP Software Version 2.0 & 2.1, Part Number 626554 FC 500 MPL 733313...

Name: Z-0317-2007 FC 500 MPL Flow Cytometry System with MXP Software Version 2.0 & 2.1, Part Number 626554 FC 500 MPL 733313...
Creator: Beckman Coulter Inc
Published: 2006-10-17
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2006-10-17 / Terminated

FDA source

Beckman Coulter Inc began a recall of FC 500 MPL Flow Cytometry System with MXP Software Version 2.0 & 2.1, Part Number 626554 FC 500 MPL 733313 MPL Hardware Upgrade Kit on 2006-10-17. The reason FDA records is "The ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the Parameter Selection Dialog box is accessed. Issue limited only to protocols utilizing the Ratio parameter such...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0317-2007
Status: Terminated
Initiated: 2006-10-17
Posted: 2006-12-27
Terminated: 2012-02-29
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: FC 500 MPL Flow Cytometry System with MXP Software Version 2.0 & 2.1, Part Number 626554 FC 500 MPL 733313 MPL Hardware Upgrade Kit
Product code: GKZ Counter, Differential Cell
Reason for recall: The ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the Parameter Selection Dialog box is accessed. Issue limited only to protocols utilizing the Ratio parameter such as LeukoSure and DNA Cell Cycle.
FDA root cause: Other
Action: A Product Corrective Action (PCA) letter was mailed on Oct 17, 2006 to FC500 MPL and MXP software accounts. They are informed that if the operator opens the Parameter Selection Dialogue box after parameters have been selected for the RATIO Parameter, the selected parameters could revert back to the default choices. If these same parameters were used in the creation of the RATIO Parameter in any other saved protocol, the protocols will also be changed once they are opened after the error occurs. An immediate user preventive action to remedy this issue each time acquisition of samples that require a protocol utilizing the ratio parameter is desired is given within the letter. Consignees are asked to complete and return the enclosed Response Form within 10 days.
Quantity in commerce: 37 units in the US; 4 units in Canada
Distribution: Nationwide and Canada
Product codes and lots: System with MXP Software Version 2.0 & 2.1

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)