BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1433-04 · Initiated August 12, 2004

    Recall

    Recall Number
    Z-1433-04
    Event Number
    29880
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 12, 2004
    Posted
    September 2, 2004
    Terminated
    April 26, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    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.

    Reason

    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.

    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.

    Distribution

    Nationwide & Canada

    Quantity

    222