Z-0669-03

LH 700 Series Hematology Analyzers. Part numbers 66056032, 6605633, 6605645

Name: Z-0669-03 LH 700 Series Hematology Analyzers. Part numbers 66056032, 6605633, 6605645
Creator: Beckman Coulter Inc
Published: 2002-12-27
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2002-12-27 / Terminated / root cause: software

FDA source

Beckman Coulter Inc began a recall of LH 700 Series Hematology Analyzers. Part numbers 66056032, 6605633, 6605645 on 2002-12-27. The reason FDA records is "Incorrect Hemoglobin result can be reported with software version 2A and higher". 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-0669-03
Status: Terminated
Initiated: 2002-12-27
Posted: 2003-03-21
Terminated: 2003-07-26
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: LH 700 Series Hematology Analyzers. Part numbers 66056032, 6605633, 6605645
Product code: GKZ Counter, Differential Cell
Reason for recall: Incorrect Hemoglobin result can be reported with software version 2A and higher.
Root cause tag: software
FDA root cause: Other
Action: Customers were contacted by telephone and mail from 1/27/03 to 2/3/2003. Notice included modified operating instructions. A software fix is being developed and will be installed by Beckman personnel.
Quantity in commerce: 234
Distribution: Nationwide and Canada.
Product codes and lots: All instruments with version 2A or higher.

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)