Z-0021-2013Class II

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

Name: Z-0021-2013 Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a...
Creator: Beckman Coulter Inc.
Published: 2012-04-03
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-04-03 / Terminated / root cause: design

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 2012-04-03. FDA classified it as Class II and gives the reason as "Beckman Coulter is recalling the UniCel DxH 800 Coulter Cellular Analysis System because the NRBC, Differential or Reticulocyte mix chamber drain ports may become plugged by rubber pieces from specimen tube caps, and...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0021-2013
Classification: Class II
Status: Terminated
Initiated: 2012-04-03
Posted: 2012-10-09
Terminated: 2013-06-20
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 a: " 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: Beckman Coulter is recalling the UniCel DxH 800 Coulter Cellular Analysis System because the NRBC, Differential or Reticulocyte mix chamber drain ports may become plugged by rubber pieces from specimen tube caps, and result in biohazard or chemical exposure and/or the potential for generating incorrect results.
Root cause tag: design
FDA root cause: Device Design
Action: Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated April 3, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were asked to complete and return an enclosed Response Form. Customers were notified that Beckman Coulter is in the process of developing and testing a design change that will prevent the mix chamber waste port from plugging. Customers with questions were instructed to contact Beckman Coulter Customer service at (800) 526-7694 in the US and Canada or contact their local Beckman Coulter representative.
Quantity in commerce: 1281 units total (693 units in the US)
Distribution: Worldwide Distribution-USA (nationwide) and the counties of Australia, Belgium, Canada, Colombia, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Republic of Kuwait, Macao, Malaysia, Mexico, Netherlands, Norway, Oman, Panama, Philippines, Puerto Rico, Qatar, Romania, Russian, Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.
Product codes and lots: all serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0021-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0021-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-09

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)