{
  "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": "210461",
      "product_res_number": "Z-0464-2025",
      "event_date_initiated": "2024-09-30",
      "event_date_posted": "2024-11-14",
      "recall_status": "Open, Classified",
      "res_event_number": "95513",
      "product_code": "MTF",
      "pma_numbers": [
        "P930027"
      ],
      "product_description": "IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)",
      "code_info": "SMN 10706281: UDI - 00630414982212, Lot Number D164;\nSMN 10706282: UDI - 00630414982229, Lot Number D166;\nSMN 10380896 (OUS):  UDI - 00630414961958;\nSMN 10380996 (OUS):  UDI - 00630414961965;\nOUS Lot Numbers: 438, 439, 440",
      "firm_fei_number": "1219913",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "333 Coney St",
      "city": "East Walpole",
      "state": "MA",
      "postal_code": "02032-1516",
      "reason_for_recall": "The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000 XPi analyzers did not meet the High-dose Hook Effect claim as stated in the Instructions for Use (IFU).",
      "root_cause_description": "Under Investigation by firm",
      "action": "An Urgent Medical Device Correction letter dated 9/30/24 was sent to customers.\n\nCustomer Actions\n\" Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, that may have been affected.\n\" Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days.\n\" Please retain this letter with your laboratory records and forward this letter to those who may have received this product.\n\nResolution\nIMMULITE 2000 and IMMULITE 2000 XPi kit lots D168 and above meet the IFU high-dose hook effect claim.\nSiemens continues to investigate root cause of the issue observed with the impacted kit lots.\n\nIf you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.\n\nPlease send a scanned copy of the completed form via email to uscctsfcaecfax.team@siemens-healthineers.com.\n\nOr to fax this completed form to the Customer Care Center at (312) 275-7795.",
      "product_quantity": "7,332 units",
      "distribution_pattern": "Worldwide - US Nationwide distribution.",
      "openfda": {
        "pma_number": [
          "P910007",
          "P020027",
          "P040008",
          "P930027",
          "P170037",
          "P950021",
          "P990056",
          "P240021",
          "P000021",
          "P980007",
          "P910065",
          "P850048"
        ],
        "registration_number": [
          "1219913",
          "2432235",
          "9612316",
          "8031673",
          "3005333358",
          "3008344661",
          "2029372",
          "2517506",
          "9610126",
          "3005529799",
          "2122870",
          "3002809144",
          "3002806944"
        ],
        "fei_number": [
          "3002808328",
          "1219913",
          "2432235",
          "2967",
          "3008344661",
          "3002806559",
          "3005333358",
          "1000306617",
          "2517506",
          "3005529799",
          "2122870",
          "3002809144",
          "3002806944"
        ],
        "device_name": "Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}