Z-1905-2010

Unicel DxH 800 Coulter Cellular Analysis System, Part number(s): 629029

Name: Z-1905-2010 Unicel DxH 800 Coulter Cellular Analysis System, Part number(s): 629029
Creator: Beckman Coulter Inc.
Published: 2009-07-28
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2009-07-28 / Terminated

FDA source

Beckman Coulter Inc. began a recall of Unicel DxH 800 Coulter Cellular Analysis System, Part number(s): 629029 on 2009-07-28. The reason FDA records is "The recall was initiated after Beckman Coulter confirmed an issue with the UniCel DxH 800 during in-house testing. It was determined that there is a potential for a false increase in platelet results, due to...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1905-2010
Status: Terminated
Initiated: 2009-07-28
Posted: 2010-06-25
Terminated: 2012-04-04
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Unicel DxH 800 Coulter Cellular Analysis System, Part number(s): 629029
Product code: GKZ Counter, Differential Cell
Reason for recall: The recall was initiated after Beckman Coulter confirmed an issue with the UniCel DxH 800 during in-house testing. It was determined that there is a potential for a false increase in platelet results, due to micro-bubbles. This situation could present a risk of falsely increased platelet results in patient samples as diluent containers are depleted.
FDA root cause: Other
Action: Beginning on July 29, 2009 Customers were contacted by Customer Technical Support (CTS) personnel and provided with the Product Corrective Action (PCA) letter. The PCA letter informed customers of the issue, the impact of the issue and actions/resolutions required by Beckman Coulter Service representative ad the affected consignee. The consignees were informed that their Beckman Coulter Service representative has made temporary changes to the Supplies setup. In addition to the Supplies setup change, consignees were instructed that one of the following workflow options must be implemented to ensure no results are affected. Please continue to follow one of the options listed below until a permanent fix is available. These options were given as: Option A: Monitor Diluent cycles or Option B: Unable to monitor Diluent cycles. The consignees were instructed that a long term solution to eliminate this risk is being developed and will be provided as soon as available. The consignees were instructed to please share this information with your laboratory staff. If they have any questions regarding this Product Corrective Action, please call 800-526-7694 in the United States or contact your local Beckman Coulter Representative.
Quantity in commerce: 7
Distribution: Nationwide to: AZ, LA, IL, NY, PA & TN
Product codes and lots: Serial Numbers: AN07020, AN05001, AN05004, AM44041, AN07015, AM51052, AN10031

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)