{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "199871",
      "product_res_number": "Z-1676-2023",
      "event_date_initiated": "2022-11-18",
      "event_date_posted": "2023-06-02",
      "recall_status": "Open, Classified",
      "res_event_number": "92205",
      "product_code": "QRF",
      "pma_numbers": [
        "P190022"
      ],
      "product_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.",
      "code_info": "UDI: 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": "800-229-5227",
      "reason_for_recall": "SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results",
      "root_cause_description": "Software Design Change",
      "action": "Customers were notified via telephone between 11/18/22 and 12/31/22.\n\nIn addition, the following information was provided within the corrected test results sent to customers:\n\n 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.",
      "product_quantity": "1 system (662 Patients test results affected)",
      "distribution_pattern": "US Nationwide distribution in the state of New Jersey.",
      "openfda": {
        "pma_number": [
          "P200048",
          "P190022"
        ],
        "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"
      }
    }
  ]
}