Z-0905-04

Coulter LH750 Hematology Analyzer. Part Number 6605632

Name: Z-0905-04 Coulter LH750 Hematology Analyzer. Part Number 6605632
Creator: Beckman Coulter Inc
Published: 2004-03-31
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2004-03-31 / Terminated

FDA source

Beckman Coulter Inc began a recall of Coulter LH750 Hematology Analyzer. Part Number 6605632 on 2004-03-31. The reason FDA records is "If a customer enters a dilution factor for Sample B prior to the results from Sample A being transfered to the workstation, the predilute multiplication factor will be applied erroneously to the Sample A's results once...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0905-04
Status: Terminated
Initiated: 2004-03-31
Posted: 2004-07-20
Terminated: 2012-04-30
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Coulter LH750 Hematology Analyzer. Part Number 6605632.
Product code: GKZ Counter, Differential Cell
Reason for recall: If a customer enters a dilution factor for Sample B prior to the results from Sample A being transfered to the workstation, the predilute multiplication factor will be applied erroneously to the Sample A's results once they are received at the workstation.
FDA root cause: Other
Action: A Product Corrective Action Letter was mailed to all customers who currently have the instrument in thier lab. The letter includes a description of what conditions need to be met for the error to occur and the proper steps to prevent the issue from occuring. The letter was sent by US Mail on March 31, 2004.
Quantity in commerce: 981
Distribution: Nationwide and Canada
Product codes and lots: Software versions 2A2 and 2B1.

Product code GKZ

K011342Class IICoulter Lh 750 Hematology Analyzer, Model 6605632Beckman Coulter, Inc. / cleared 2001-07-09

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)