{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "196092",
      "product_res_number": "Z-0094-2023",
      "event_date_initiated": "2022-08-30",
      "event_date_posted": "2022-10-14",
      "recall_status": "Open, Classified",
      "res_event_number": "90867",
      "product_code": "CFN",
      "k_numbers": [
        "K083445"
      ],
      "product_description": "N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD\t\t\t\nSiemens Material Number (SMN): 10446299",
      "code_info": "UDI-DI:  0405686900179VF\nLot Number: \n153083;\n153085;\n153087A;\n153090;\n153095B;\n153099A;\n153004B.\n\nFuture lots may be impacted by the issue but will then be provided with a corresponding instruction note within the reagent package",
      "firm_fei_number": "3014838736",
      "recalling_firm": "SIEMENS HEALTHCARE DIAGNOSTICS INC",
      "address_1": "511 Benedict Ave",
      "city": "Tarrytown",
      "country": "Spain",
      "reason_for_recall": "N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF).",
      "root_cause_description": "Under Investigation by firm",
      "action": "Siemens Healthcare Diagnostics  issued an Urgent Medical Device Correction (UMDC) PP-22-003-A-C US to US customers by FedEx on 08/30/2022; and Urgent Field Safety Notice (UFSN) PP-22-003-A-C OUS -all OUS Siemens reporting sites with affected customers, for distribution and regional reporting to their local competent authorities beginning on 08/19/2022. Letter states reason for recall, health risk and action to take:\nPlease review this letter with your Medical Director.\nDiscontinue use of N Antiserum to Human IgG lot 153095B for urine and CSF sample determination. However, the N Antiserum to Human IgG lot 153095B can still be used for serum sample determination.\nAll other N Antiserum to Human IgG lots listed in Table 1 can continue to be used with the following new preliminary high dose hook thresholds for urine and CSF:\n\" Urine: 395 mg/L\n\" CSF: 412 mg/L\nFurther information regarding establishment of the preliminary high dose hook threshold can be found within section  Additional Information .\n\" The specified high dose hook threshold for serum (83.3 g/L) remains unchanged for all N Antiserum to Human IgG lots.\nAccording to the IFU, in case of questionable results, the determinations should be repeated using the next higher sample dilution. For patient monitoring, consecutive immunoglobulin determinations should be performed from the same sample dilution, as far as possible.\nReview your inventory of the N Antiserum to Human IgG lot 153095B to determine your laboratory s replacement needs, if required, and to provide information to Siemens Healthineers for reporting to the authorities.\n\nComplete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days.\nPlease retain this letter with your laboratory records and forward this letter to those who may have received this product.\nIf you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.",
      "product_quantity": "10,201 packs",
      "distribution_pattern": "Nationwide",
      "openfda": {
        "k_number": [
          "K150526",
          "K162208",
          "K022083",
          "K130122",
          "K191465",
          "K781654",
          "K981912",
          "K221114",
          "K871343",
          "K993924",
          "K061845",
          "K120750",
          "K120901",
          "K933973",
          "K012295",
          "K090920",
          "K090594",
          "K012292",
          "K781656",
          "K923070",
          "K993549",
          "K103824",
          "K081161",
          "K192116",
          "K981784",
          "K933970",
          "K042152",
          "K073561",
          "K860894",
          "K233663",
          "K042475",
          "K771226",
          "K191635",
          "K982382",
          "K042735",
          "K073487",
          "K982100",
          "K061338",
          "K073490",
          "K000701",
          "K781655",
          "K072889",
          "K012291",
          "K191985",
          "K880356",
          "K082129",
          "K082823",
          "K081827",
          "K032014",
          "K120749",
          "K100588",
          "K190686",
          "K073489",
          "K113823",
          "K183151",
          "K142735",
          "K083445",
          "K012296",
          "K864342",
          "K993547",
          "K933971"
        ],
        "registration_number": [
          "3003795116",
          "1319808",
          "9610529",
          "2432235",
          "9614373",
          "2050012",
          "3012471076",
          "9610126",
          "2050010",
          "3012963943",
          "9610806",
          "3011989923",
          "1319681",
          "3002642396",
          "3000308930",
          "2250051",
          "9680746",
          "3004493545",
          "3000148879",
          "3006198300"
        ],
        "fei_number": [
          "3003795116",
          "3002808340",
          "1000305841",
          "2432235",
          "2050012",
          "3012471076",
          "2050010",
          "1000206808",
          "3012963943",
          "3011989923",
          "3002642396",
          "3000308930",
          "2250051",
          "3002806560",
          "3004493545",
          "1000136573",
          "3000148879",
          "3001644026",
          "3006198300",
          "3002806559"
        ],
        "device_name": "Method, Nephelometric, Immunoglobulins (G, A, M)",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5510",
        "device_class": "2"
      }
    }
  ]
}