BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported June 14, 2023

    Enforcement

    Recall Number
    Z-1676-2023
    Event ID
    92205
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    BioReference Health, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 14, 2023
    Initiation Date
    November 18, 2022
    Classification Date
    June 2, 2023
    Address
    481 Edward H Ross Dr, Elmwood Park, NJ, 07407-3118, United States

    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

    Code Info

    UDI: 00850038860004

    Distribution

    US Nationwide distribution in the state of New Jersey.

    Quantity

    1 system (662 Patients test results affected)