Z-0432-2016Class II

UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 629029, B24465, B24802...

Name: Z-0432-2016 UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 629029, B24465, B24802...
Creator: Beckman Coulter Inc.
Published: 2015-12-01
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-12-01 / Terminated / root cause: software

FDA source

Beckman Coulter Inc. began a recall of UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 629029, B24465, B24802 The UniCel DxH 800/DxH 600 analyzers are... on 2015-12-01. FDA classified it as Class II and gives the reason as "Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 software version 1.1.1.0 because the software for the DxH systems allows the creation of multiple orders with the same...". 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-0432-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-01
Posted: 2015-12-16
Terminated: 2017-01-20
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 629029, B24465, B24802 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is available as an analyzer for use on a benchtop or with a floor stand. The DxH 600 is available as an analyzer for use on a benchtop only.
Product code: GKZ Counter, Differential Cell
Reason for recall: Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 software version 1.1.1.0 because the software for the DxH systems allows the creation of multiple orders with the same Specimen identification (ID) but different Patient identification when manually editing pending orders at the System Manager.
Root cause tag: software
FDA root cause: Software design
Action: Beckman Coulter sent an Urgent Medical Device Recall letter dated December 1, 2015, to all affected customers to inform them that Beckman Coulter is recalling the the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 software version 1.1.1.0 because of the possibility of sample misidentificaton. Customers were informed that during internal testing, Beckman Coulter determined that the software for the DxH systems noted above allows the creation of multiple orders with the same Specimen identification (ID) but different Patient identification when manually editing pending orders at the System Manager. The issue does not occur for edits of released results or for test orders requested through host transmission. Customers were instructed to complete and return the enclosed response form within 10 days. Customers with questions were instructed to contact Customer Support Center at www.beckmancoulter.com/customersupport/support or via phone (800) 526-7694 in US and Canada. Customers outside of US and Canada are instructed to contact their local Beckman Coulter Representative. For questions regarding this recall call 714-961-5321.
Quantity in commerce: 3,951 units total (1,975 units in US)
Distribution: Worldwide Distribution - US (nationwide) and Internationally to Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brunei Darussalam, Canada, China, Colombia, Croatia, Czech Republic, Ecuador, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Republic of Korea, Kuwait, Lebanon, Lithuania, Macao, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Norway, Oman, Panama Philippines, Poland, Portugal, Puerto Rico , Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Republic, United Kingdom, Uruguay, and Vietnam.
Product codes and lots: all serial numbers Part Nos. 629029, B24465, B24802

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0432-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0432-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-23	2015-12-16
Z-0433-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-23	2015-12-16
Z-0434-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-23	2015-12-16

Product code GKZ

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)