{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "203329",
      "product_res_number": "Z-0516-2024",
      "event_date_initiated": "2023-10-31",
      "event_date_posted": "2023-12-08",
      "recall_status": "Open, Classified",
      "res_event_number": "93050",
      "product_code": "QRF",
      "pma_numbers": [
        "P190022"
      ],
      "product_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).",
      "code_info": "UDI-DI: 00850038860004",
      "firm_fei_number": "3003652672",
      "recalling_firm": "BioReference Health, LLC",
      "address_1": "481 Edward H Ross Dr",
      "city": "Elmwood Park",
      "state": "NJ",
      "postal_code": "07407-3118",
      "additional_info_contact": "833-457-2673",
      "reason_for_recall": "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.",
      "root_cause_description": "Device Design",
      "action": "A notification letter dated 10/31/23 was sent to customers.\n\nAs 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.\n\nAs 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.\n\nIf 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: 4kcustomerservice@bioreference.com. Thank you again for allowing BioReference Health to assist you in the care of your patients with potential prostate cancer.\n\nPlease respond using the page following this letter, by fax 201-663-4113, or email: 4kcustomerservice@bioreference.com to confirm receipt of thi",
      "product_quantity": "1 system (3,196 tests)",
      "distribution_pattern": "US Nationwide distribution.",
      "openfda": {
        "pma_number": [
          "P190022",
          "P200048"
        ],
        "registration_number": [
          "3011015335",
          "3003652672",
          "3003559457"
        ],
        "fei_number": [
          "3011015335",
          "3003652672",
          "3003559457"
        ],
        "device_name": "Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}