BEUDAMED
    FDA Recall Open, Classified

    The 4Kscore Test, 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 patient s age, previous biopsy, and digital rectal exam (DRE).

    Recall: Z-0516-2024 · Initiated October 31, 2023

    Recall

    Recall Number
    Z-0516-2024
    Event Number
    93050
    Firm
    BioReference Health, LLC
    FEI Number
    3003652672
    Product Code
    QRF
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    October 31, 2023
    Posted
    December 8, 2023
    Address
    481 Edward H Ross Dr, Elmwood Park, NJ, 07407-3118

    Description

    The 4Kscore Test, 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 patient s age, previous biopsy, and digital rectal exam (DRE).

    Reason

    Mathematical modeling of the 4Kscore with and without DRE information was recently performed on over 3,000 specimens. DRE information is a required component of The 4Kscore Test.

    Action

    A notification letter dated 10/31/23 was sent to customers. As of the FDA approval of 4Kscore in December 2021, only results with a digital rectal examination (DRE) input of Nodule or No Nodule are considered as valid. Customers who received 4Kscore results without having DRE information inputted (e.g., no information entered for Nodule or No Nodule ) are advised that these results may have increased uncertainty, potentially resulting in erroneous decision interpretations, as DRE information is required for the interpretation recommendations contained in the PMA approved device labeling. The device has now been modified such that if the required DRE information is not provided (e.g., no information entered for Nodule or No Nodule ), then the blood sample will be frozen and stored at our laboratory for up to 60 days, and 4Kscore results will not be performed unless the required DRE information is provided within 60 days. As per the package insert, the DRE cannot be performed within 96 hours before sample collection, but it can be performed after phlebotomy, or in the preceding 12 months before testing. If it is more convenient to schedule the DRE in an office visit after the blood draw, blood samples will be frozen and stored at our laboratory for up to 60 days. The required DRE information can be provided to our customer service center within that me, and the sample will be tested once this information is received. No results will be reported if the input of Nodule or No Nodule information is not received by 60 days. If there are any questions, please feel free to reach out by telephone: 1-833-4KSCORE (1-883-457-2673), Fax: 201-663-4113, or email: [email protected]. Thank you again for allowing BioReference Health to assist you in the care of your patients with potential prostate cancer. Please respond using the page following this letter, by fax 201-663-4113, or email: [email protected] to confirm receipt of thi

    Distribution

    US Nationwide distribution.

    Quantity

    1 system (3,196 tests)