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.
FDA Recall Z-1433-04 · Posted 2004-09-02
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Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeGKZ
Date Initiated2004-08-12
Date Terminated2012-04-26
Product Quantity222
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide & Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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