Z-2114-2011

UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029 The UniCel DxH 800 Analyzer is a...

Name: Z-2114-2011 UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029 The UniCel DxH 800 Analyzer is a...
Creator: Beckman Coulter Inc.
Published: 2010-10-20
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-10-20 / Terminated

FDA source

Beckman Coulter Inc. began a recall of UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029 The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro... on 2010-10-20. The reason FDA records is "For Panels containing CBC: The RBC and HCT are improperly corrected and not flagged when there is a WBC Pump Failure and the WBC ~ 140x103/uL. For Body Fluid Panels: The RBC is improperly corrected and not flagged when...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2114-2011
Status: Terminated
Initiated: 2010-10-20
Posted: 2011-04-29
Terminated: 2014-09-02
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029 The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides: - Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood - Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF)
Product code: GKZ Counter, Differential Cell
Reason for recall: For Panels containing CBC: The RBC and HCT are improperly corrected and not flagged when there is a WBC Pump Failure and the WBC ~ 140x103/uL. For Body Fluid Panels: The RBC is improperly corrected and not flagged when there is a WBC Pump Failure. IMPACT: Erroneous RBC and/or HCT could affect the interpretation and management of patients at risk with various types of anemias.
FDA root cause: Other
Action: The recall communication was initiated on 10/20/2010, with Beckman Coulter forwarding a Product Corrective Action (PCA) letter with PCA Response Form (via US Postal Service for US customers) to all customers who purchased the UniCel DxH 800 Coulter Cellular Analysis System. This letter informs the customers about the problems identified and provides an action/resolution to this issue. When a WBC Pump Failure occurs, the WBC or TNC results will be flagged with 'R' and the WBC Pump Failure System message. The RBC and/or HCT results associated with these affected analyses also require review. This will be corrected in a future version of software. Beckman Coulter asked consignees to complete and return the enclosed response form within 10 days and share this information with laboratory staff and retain this notification as part of laboratory Quality System documentation. Questions were directed to Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or consignees local Beckman Coulter representative.
Quantity in commerce: 422 units in total (175 in US)
Distribution: Nationwide in the US and worldwide to: Australia, Belgium, Canada, Colombia, Croatia, France, Germany, Greece, Hong Kong, India, Italy, Japan, Korea, Republic of, Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Turkey and United Kingdom
Product codes and lots: All serial numbers, SW version 1.1.3.0

Product code GKZ

K081930Class IIUnicel Dxh 800 Coulter Cellular Analysis SystemBeckman Coulter, Inc. / cleared 2008-12-19

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)