Z-0566-2007

Coulter LH700 Series Hematology Analyzers, Part Number 6605632 with 2B Software (2B3, 2B4 and 2B5)

Name: Z-0566-2007 Coulter LH700 Series Hematology Analyzers, Part Number 6605632 with 2B Software (2B3, 2B4 and 2B5)
Creator: Beckman Coulter Inc
Published: 2006-09-12
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2006-09-12 / Terminated / root cause: labeling and UDI

FDA source

Beckman Coulter Inc began a recall of Coulter LH700 Series Hematology Analyzers, Part Number 6605632 with 2B Software (2B3, 2B4 and 2B5) on 2006-09-12. The reason FDA records is "There is a potential for erroneous yet credible results for Body Fluids on the LH700 series hematology analyzers when a cassette label fails to read and the subsequent sample is cycled in Body Fluid mode". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0566-2007
Status: Terminated
Initiated: 2006-09-12
Posted: 2007-03-06
Terminated: 2012-04-19
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Coulter LH700 Series Hematology Analyzers, Part Number 6605632 with 2B Software (2B3, 2B4 and 2B5)
Product code: GKZ Counter, Differential Cell
Reason for recall: There is a potential for erroneous yet credible results for Body Fluids on the LH700 series hematology analyzers when a cassette label fails to read and the subsequent sample is cycled in Body Fluid mode.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: A Product Corrective Action (PCA) letter was mailed on Sep 12, 2006 to all LH 750 accounts to inform them that there is an issue with COULTER LH 700 Series analyzer software that could affect the Body Fluid analysis and that this this anomaly is present only in Software revisions of 2B. The letter instructs the customer on how to determine their software version. Immediate user preventive action was provided in the letter which is to reset the analyzer when a cassette label read error occurs. The letter advises that this information be shared with laboratory staff and be retained as part of their Quality System documentation. A customer response form was also included.
Quantity in commerce: 1893 units in the US; 94 units to Canada
Distribution: Nationwide and Canada
Product codes and lots: Part Number 6605632, with 2B Software (2B3, 2B4 and 2B5)

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)