Z-1980-2011

UniCel DxH 800 Floor Cabinet Part Number: 723335 The UniCel DxH 800 Analyzer is a quantitative, automated...

Name: Z-1980-2011 UniCel DxH 800 Floor Cabinet Part Number: 723335 The UniCel DxH 800 Analyzer is a quantitative, automated...
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 Floor Cabinet Part Number: 723335 The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in... on 2010-10-20. The reason FDA records is "Sharp edges on drawer slides within the DxH800 Floor Stand (Cabinet) may expose operators to physical injury while replacing reagents and waste containers. IMPACT: There is potential for exposure to blood borne...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1980-2011
Status: Terminated
Initiated: 2010-10-20
Posted: 2011-04-14
Terminated: 2012-04-02
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: UniCel DxH 800 Floor Cabinet Part Number: 723335 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: Sharp edges on drawer slides within the DxH800 Floor Stand (Cabinet) may expose operators to physical injury while replacing reagents and waste containers. IMPACT: There is potential for exposure to blood borne pathogens such as HIV, HBV, and HCV.
FDA root cause: Other
Action: Beckman Coulter sent an Urgent Product Corrective Action letter dated October 20, 2010, with a PCA Response Form (via US PostalService) to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. This letter informed the customers about the problems identified and provided an action/resolution to this issue. 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: Worldwide Distribution - USA (nationwide) and the countries of 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)