Z-1657-2010

Coulter LH 500 Series System. Beckman Coulter, Inc. Brea, CA. Quantitative, automated hematology analyzer and...

Name: Z-1657-2010 Coulter LH 500 Series System. Beckman Coulter, Inc. Brea, CA. Quantitative, automated hematology analyzer and...
Creator: Beckman Coulter Inc.
Published: 2010-02-04
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-02-04 / Terminated / root cause: software

FDA source

Beckman Coulter Inc. began a recall of Coulter LH 500 Series System. Beckman Coulter, Inc. Brea, CA. Quantitative, automated hematology analyzer and leukocyte differential cell counter for in vitro... on 2010-02-04. The reason FDA records is "Issue 1: The system will substitute or omit the characters # @ [\] ' {I) when the system is configured in a language other than English or Chinese. Example: Using the character @, a substitution in the string '123@456'...". 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-1657-2010
Status: Terminated
Initiated: 2010-02-04
Posted: 2010-05-26
Terminated: 2014-09-02
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Coulter LH 500 Series System. Beckman Coulter, Inc. Brea, CA. Quantitative, automated hematology analyzer and leukocyte differential cell counter for in vitro diagnostic use in clinical laboratories.
Product code: GKZ Counter, Differential Cell
Reason for recall: Issue 1: The system will substitute or omit the characters # @ [\] ' {I) when the system is configured in a language other than English or Chinese. Example: Using the character @, a substitution in the string '123@456' would result in '123#456' and an omission would result in '123456' Issue 2: The system will omit the character ~ regardless of language. Impact: There is a potential for Specimen
Root cause tag: software
FDA root cause: Software design
Action: Beckman Coulter, Inc. issued "Urgent: Product Corrective Action" notifications dated February 12, 2010. Consignees were informed of the affected product and instructed on proper actions. The firm also asked that the enclosed response forms be returned. For further information, contact your local Beckman Coulter Representative or call 1-800-526-7694.
Quantity in commerce: 1520 units
Distribution: Distributed Nationwide and Canada.
Product codes and lots: Product LH500 100V Part number 178832; Product LH500 120V Part number 178833; Product LH500 240V Part Number 178834; All Serial Numbers.

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)