Z-2227-2011

Unicel DxH 800 Coulter Cellular Analysis System. A quantitative, automated hematology analyzer for in vitro...

Name: Z-2227-2011 Unicel DxH 800 Coulter Cellular Analysis System. A quantitative, automated hematology analyzer for in vitro...
Creator: Beckman Coulter Inc.
Published: 2011-04-14
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2011-04-14 / Terminated / root cause: software

FDA source

Beckman Coulter Inc. began a recall of Unicel DxH 800 Coulter Cellular Analysis System. A quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations... on 2011-04-14. The reason FDA records is "The recall was initiated because Beckman Coulter has confirmed the auto prune will not remove patient results if the patient record includes demographics where the results are less than 30 days old". 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-2227-2011
Status: Terminated
Initiated: 2011-04-14
Posted: 2011-05-20
Terminated: 2012-05-23
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Unicel DxH 800 Coulter Cellular Analysis System. A 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 recall was initiated because Beckman Coulter has confirmed the auto prune will not remove patient results if the patient record includes demographics where the results are less than 30 days old.
Root cause tag: software
FDA root cause: Software design
Action: The recall communication was initiated on 4/12/11 with Beckman Coulter forwarding an Urgent Product Correction (PC) letter with attached PC Response Form (via US Postal Service for US customers) to all customers who purchased the UniCel DxH" 800 Coulter Cellular Analysis System PN 629029. The letter provides customers with an explanation of the problem identified and an action to be taken. For Issue 1 & 2, customers were instructed to perform manual database maintenance procedures to locate and delete unnecessary patient result and demographic information that extends beyond the life (in days) of the control lots. Ensure an alternative method of analysis is available during database maintenance. For Issue 3, customers were instructed to not attempt to transmit the files again after receiving an incomplete report. Instead, submit the missing file(s) by one of the following methods: - Submit your data at the electronic IQAP website (eIQAP) at (http://www.beckmancoulter.com/qap/index.jsp) - Fax printouts of the missing files to 786-639-3999 - Email an electronic copy (.CSV) of the control file to [email protected]. - Include the IQAP number on any communication. A corrected report will be returned to the customers' laboratories. For issue 4, customers were instructed to submit their control data to IQAP by one of the following methods: -Submit their data at the electronic IQAP website (eIQAP) at (http://www.beckmancoulter.com/qap/index.jsp) -Fax printouts of the missing files to 786-639-3999 -Email an electronic copy (.CSV) of the control file to [email protected]. -Include your IQAP number on any communication. Customers were instructed to complete and return the enclosed Response Form within ten days. Customers were instructed to contact Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or contact their local Beckman Coulter representative.
Quantity in commerce: 673 units
Distribution: Worldwide Distribution -- US, Canada, Australia, Belgium, Colombia, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Republic of Korea, Macao, Malaysia, Myanmar, Netherlands, Norway, Philippines, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.
Product codes and lots: Part # 629029

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)