Z-1680-2010

UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029. Beckman Coulter, Inc. Brea, CA...

Name: Z-1680-2010 UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029. Beckman Coulter, Inc. Brea, CA...
Creator: Beckman Coulter Inc.
Published: 2009-12-08
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2009-12-08 / Terminated / root cause: software

FDA source

Beckman Coulter Inc. began a recall of UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029. Beckman Coulter, Inc. Brea, CA. Quantitative, automated hematology analyzer for in vitro... on 2009-12-08. The reason FDA records is "The Corrective Action was initiated after Beckman Coulter confirmed three issues related to host transmissions with the UniCel DxH 800. This information only affects instruments interfaced to a host system". 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-1680-2010
Status: Terminated
Initiated: 2009-12-08
Posted: 2010-05-26
Terminated: 2012-06-04
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029. Beckman Coulter, Inc. Brea, CA. Quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.
Product code: GKZ Counter, Differential Cell
Reason for recall: The Corrective Action was initiated after Beckman Coulter confirmed three issues related to host transmissions with the UniCel DxH 800. This information only affects instruments interfaced to a host system.
Root cause tag: software
FDA root cause: Software design
Action: Beckman Coulter, Inc. issued an "Urgent: Product Corrective Action" notification dated December 8, 2009. Consignees were informed of the affected product and provided temporary solutions until further support will be made available. For additional information, contact your local Beckman Coulter Representative or call 800-526-7694.
Quantity in commerce: 42 units (40 in US)
Distribution: Distributed Nationwide and Canada.
Product codes and lots: All Serial Numbers

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)