Z-1433-04

COULTER LH 500 Hematology Analyzer part numbers: 178832, 178833, and 178834 software versions 1A and 1A2. The...

Name: Z-1433-04 COULTER LH 500 Hematology Analyzer part numbers: 178832, 178833, and 178834 software versions 1A and 1A2. The...
Creator: Beckman Coulter Inc
Published: 2004-08-12
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2004-08-12 / Terminated

FDA source

Beckman Coulter Inc began a recall of COULTER LH 500 Hematology Analyzer part numbers: 178832, 178833, and 178834 software versions 1A and 1A2. The LH 500 Analyzer is a quantitative, automated... on 2004-08-12. The reason FDA records is "Beckman Coulter has confirmed an issue associated with the predilute mode of the COULTER LH 500 Hematology Analyzer. The workstation may display, transmit, and / or print an erroneous result or an incorrect dilution...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1433-04
Status: Terminated
Initiated: 2004-08-12
Posted: 2004-09-02
Terminated: 2012-04-26
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: COULTER LH 500 Hematology Analyzer part numbers: 178832, 178833, and 178834 software versions 1A and 1A2. The LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter For In Vitro Diagnostic Use in clinical laboratories. The LH %500 Analyzer also provides a semi-automated reticulocyte analysis.
Product code: GKZ Counter, Differential Cell
Reason for recall: Beckman Coulter has confirmed an issue associated with the predilute mode of the COULTER LH 500 Hematology Analyzer. The workstation may display, transmit, and / or print an erroneous result or an incorrect dilution factor with a predilute sample result.
FDA root cause: Other
Action: Customers were notified via U.S. mail by a Product Corrective Action Letter (PCA) dated August 12, 2004. 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 occurring.
Quantity in commerce: 222
Distribution: Nationwide & Canada
Product codes and lots: Part Numbers: 178832, 178833, and 178834 software versions 1A and 1A2.

Product code GKZ

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)