Z-2337-2010

COULTER LH 500 Series System

Name: Z-2337-2010 COULTER LH 500 Series System
Creator: Beckman Coulter Inc.
Published: 2010-02-12
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-02-12 / Terminated / root cause: software

FDA source

Beckman Coulter Inc. began a recall of COULTER LH 500 Series System on 2010-02-12. The reason FDA records is "The recall was initiated after Beckman Coulter identified four (4) issues with the COULTER LH 500 Series System and the Unicel DxH 800 Coulter Cellular Analysis System: Issue 1: There is a potential for...". 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-2337-2010
Status: Terminated
Initiated: 2010-02-12
Posted: 2010-09-01
Terminated: 2010-09-10
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: COULTER LH 500 Series System
Product code: GKZ Counter, Differential Cell
Reason for recall: The recall was initiated after Beckman Coulter identified four (4) issues with the COULTER LH 500 Series System and the Unicel DxH 800 Coulter Cellular Analysis System: Issue 1: There is a potential for misidentification to occur when the system is configured in languages other than English or Chinese. The characters #,@,[,\,],`,{,|,}, or ~ are substituted or omitted in other languages. The issu
Root cause tag: software
FDA root cause: Software design
Action: The customer recall notification was initiated when Product Corrrective Actions letters with attached Customer Response form were sent on the week of February 15, 2010 to all customers who purchased the COULTER LH 500 Series System and the Unicel DxH 800 Coulter Cellular Analysis System. The letters will provided the customers with an explanation of the problem identified and a work around. Customers with questions regarding the Product Corrective Action were instructed to call 800-526-7694 in the United States or Canada, or contact your local Beckman Coulter Representative.
Quantity in commerce: 1373 units in US and 147 units in Canada
Distribution: Throughout the United States and Canada
Product codes and lots: All serial Numbers.

Product code GKZ

K032000Class IICoulter Lh 500 Hematology AnalyzerBeckman Coulter, Inc. / cleared 2003-08-13

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)