Z-0536-05

COULTER LH 750 Hematology Analyzer

Name: Z-0536-05 COULTER LH 750 Hematology Analyzer
Creator: Beckman Coulter Inc
Published: 2004-12-16
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2004-12-16 / Terminated

FDA source

Beckman Coulter Inc began a recall of COULTER LH 750 Hematology Analyzer on 2004-12-16. The reason FDA records is "A rare risk of sample misidentification exists with Coulter LH 750 Hematology Analyzers. The printout results from the instrument are affected; however, the results stored in the workstation's database are not affected". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0536-05
Status: Terminated
Initiated: 2004-12-16
Posted: 2005-02-10
Terminated: 2012-04-26
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: COULTER LH 750 Hematology Analyzer.
Product code: GKZ Counter, Differential Cell
Reason for recall: A rare risk of sample misidentification exists with Coulter LH 750 Hematology Analyzers. The printout results from the instrument are affected; however, the results stored in the workstation's database are not affected.
FDA root cause: Other
Action: Letter 12/20/04 A rare risk of sample misidentification exists with Coulter LH 750 Hematology Analyzers. The printout results from the instrument are affected; however, the results stored in the workstation''s database are not affected. If the LH750 instrument displays a pop-up winder titled Database Error (XXXXXX) and text similar to (Microsoft) (ODBC SQL...) As soon as possible, call Beckman Coulter Customer Service, 800-526-7694) or contact your local rep, to schedule a service call. Do not acknowledge the error. Instead, restart the entire system by completely powering it OFF and then ON. Or, if the LH750 Workstation experiences a change in performance, such as screen display freezes, slow response time, or requires frequent resets to continue processing. As soon as possible, call Beckman Coulter Customer Service, 800-526-7694) or contact your local rep, to schedule a service call. Verify the accuracy of all patient reports for the samples until service confirms the performance of system.
Quantity in commerce: 1,257
Distribution: US and Canada
Product codes and lots: Part Number 6605632

Product code GKZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)