Z-0599-2012

Coulter LH500 Series Analyzer, Part number: 178832, 178833, 178834. LH 500 Series System Instructions for...

Name: Z-0599-2012 Coulter LH500 Series Analyzer, Part number: 178832, 178833, 178834. LH 500 Series System Instructions for...
Creator: Beckman Coulter Inc.
Published: 2011-10-13
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2011-10-13 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of Coulter LH500 Series Analyzer, Part number: 178832, 178833, 178834. LH 500 Series System Instructions for Use, PN 624602 Rev BA. The COULTER LH 500 Analyzer is... on 2011-10-13. The reason FDA records is "The recall was initiated because Beckman has identified a problem with Integrated Circuit chips used in different boards throughout the analyzer". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0599-2012
Status: Terminated
Initiated: 2011-10-13
Posted: 2012-01-11
Terminated: 2012-06-01
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Coulter LH500 Series Analyzer, Part number: 178832, 178833, 178834. LH 500 Series System Instructions for Use, PN 624602 Rev BA. The COULTER LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter For In Vitro Diagnostic Use in clinical laboratories. The LH500 Analyzer also provides a semi-automated reticulocyte analysis.
Product code: GKZ Counter, Differential Cell
Reason for recall: The recall was initiated because Beckman has identified a problem with Integrated Circuit chips used in different boards throughout the analyzer.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated October 13, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were instructed to contact Beckman Coulter Service at (800) 526-7694 if they were experiencing failures. Customers not experiencing failures, but their system may have the suspect chips, were told they would be contacted by Beckman Coulter Service to correct their problem. Customers were also instructed to complete and return an enclosed Response Form.
Quantity in commerce: 117 units total
Distribution: Worldwide Distribution.
Product codes and lots: N/A

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)