Z-1529-2008

Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager, Part Numbers 626553 and...

Name: Z-1529-2008 Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager, Part Numbers 626553 and...
Creator: Beckman Coulter Inc
Published: 2007-08-20
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2007-08-20 / Terminated / root cause: software

FDA source

Beckman Coulter Inc began a recall of Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager, Part Numbers 626553 and 6605628 A system for the qualitative and quantitative... on 2007-08-20. The reason FDA records is "Labeling provided by two integrated software systems are not clear enough to avoid potential demographic and sample type mismatches under certain conditions". 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-1529-2008
Status: Terminated
Initiated: 2007-08-20
Posted: 2008-08-08
Terminated: 2012-10-15
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager, Part Numbers 626553 and 6605628 A system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles.
Product code: GKZ Counter, Differential Cell
Reason for recall: Labeling provided by two integrated software systems are not clear enough to avoid potential demographic and sample type mismatches under certain conditions.
Root cause tag: software
FDA root cause: Software design
Action: A Product Corrective Action (PCA) letter, dated August 16, 2007, informed the customers that the User documentation and Online Help for the FC500 with Data Innovations lnstrument Manager are not clear enough to avoid potential demographic and sample type mismatches under certain conditions. The letter asks the customers to share the information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. They are also to review all sample identification, demographics, data and results before reporting results out. A response form is included. Questions and concerns regarding the notification should be directed to Beckman Coulter Customer Service at 1-800-526-7694.
Quantity in commerce: 141 units
Distribution: Worldwide Distribution --- including USA and country of Canada.
Product codes and lots: All Software Versions

Product code GKZ

K030828Class IITetracxp System (Software and System Guide)Beckman Coulter, Inc. / cleared 2003-05-21

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)