BEUDAMED
    FDA Recall Open, Classified

    The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the following information: a patients age, previous biopsy, and digital rectal exam (DRE). Patients file (sample type, prior biopsy status, DRE status and age) are uploaded to the Specimen Processing Module (SPM). The results from the four assays are exported automatically to Lab Manager Application (B2 LIS) which automatically triggers the 4Kscore calculation when values of the four analytes are available. The 4Kscore test results are determined automatically by the validated laboratory information system algorithm calculation software.

    Recall: Z-1676-2023 · Initiated November 18, 2022

    Recall

    Recall Number
    Z-1676-2023
    Event Number
    92205
    Firm
    BioReference Health, LLC
    FEI Number
    3003652672
    Product Code
    QRF
    Status
    Open, Classified
    Root Cause
    Software Design Change
    Initiated
    November 18, 2022
    Posted
    June 2, 2023
    Address
    481 Edward H Ross Dr, Elmwood Park, NJ, 07407-3118

    Description

    The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the following information: a patients age, previous biopsy, and digital rectal exam (DRE). Patients file (sample type, prior biopsy status, DRE status and age) are uploaded to the Specimen Processing Module (SPM). The results from the four assays are exported automatically to Lab Manager Application (B2 LIS) which automatically triggers the 4Kscore calculation when values of the four analytes are available. The 4Kscore test results are determined automatically by the validated laboratory information system algorithm calculation software.

    Reason

    SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results

    Action

    Customers were notified via telephone between 11/18/22 and 12/31/22. In addition, the following information was provided within the corrected test results sent to customers: The 4Kscore result has been corrected to reflect the history of a prostatic nodule and/or the prior negative biopsy result, which was inaccurately posted into the algorithm, due to a bioinformatics error.

    Distribution

    US Nationwide distribution in the state of New Jersey.

    Quantity

    1 system (662 Patients test results affected)