Z-1245-06

Coulter LH500 Hematology Analyzer: Part Numbers 178832, 178833, 178834

Name: Z-1245-06 Coulter LH500 Hematology Analyzer: Part Numbers 178832, 178833, 178834
Creator: Beckman Coulter Inc
Published: 2006-04-17
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2006-04-17 / Terminated

FDA source

Beckman Coulter Inc began a recall of Coulter LH500 Hematology Analyzer: Part Numbers 178832, 178833, 178834 on 2006-04-17. The reason FDA records is "Beckman has confirmed that erroneous results could be reported when the workstation database crashes". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1245-06
Status: Terminated
Initiated: 2006-04-17
Posted: 2006-07-18
Terminated: 2012-04-19
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Coulter LH500 Hematology Analyzer: Part Numbers 178832, 178833, 178834
Product code: LOQ Device, General Purpose, Hematology
Reason for recall: Beckman has confirmed that erroneous results could be reported when the workstation database crashes.
FDA root cause: Other
Action: A Product Corrective Action (PCA) letter was sent week of April 17, 2006 via US mail. The letter outlines action to be taken to avoid potential erroneous results. Firm targeting 75% effectivenss checks.
Quantity in commerce: 759
Distribution: Nationwide and Canada
Product codes and lots: All software versions.

Product code LOQ

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)