{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "192846",
      "product_res_number": "Z-1015-2022",
      "event_date_initiated": "2022-02-22",
      "event_date_created": "2022-04-28",
      "recall_status": "Open, Classified",
      "res_event_number": "89900",
      "product_code": "DHA",
      "k_numbers": [
        "K990222"
      ],
      "product_description": "IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog number L2KCG6]",
      "code_info": "8 production lots: 463, 464, 466, 467, 469, 470, 471, 472, [UDI for 200 tests: (01)00630414961132(10)463(17)20220228, (01)00630414961132(10)464(17)20220331, (01)00630414961132(10)466(17)20220331, (01)00630414961132(10)467(17)20220531, (01)00630414961132(10)469(17)20220731, (01)00630414961132(10)470(17)20220930, (01)00630414961132(10)471(17)20221130, (01)00630414961132(10)472(17)20230228]  \n[UDI for 600 tests: (01)00630414961149(10)463(17)20220228, \n01)00630414961149(10)464(17)20220331, (01)00630414961149(10)466(17)20220331, (01)00630414961149(10)467(17)20220531, (01)00630414961149(10)469(17)20220731, (01)00630414961149(10)470(17)20220930, (01)00630414961149(10)471(17)20221130, (01)00630414961149(10)472(17)20230228]",
      "firm_fei_number": "2432235",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "511 Benedict Ave",
      "city": "Tarrytown",
      "state": "NY",
      "postal_code": "10591-5005",
      "additional_info_contact": "Aarti Aziz, Quality Manager\n914-656-9027",
      "reason_for_recall": "Potential for falsely elevated hCG results due to sample carryover in serum and urine\npatient samples, as well as quality control samples and adjustors.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Urgent Medical Device Correction was issued February 02, 2022 via Fed Ex. Notification provides instructions to customers to mitigate this sample carryover. Customers are requested to complete and return the Effectiveness Check questionnaire. Contact your local Siemens Healthineers technical support representative with any questions.",
      "product_quantity": "10,755 boxes (533 US, 10,222 OUS)",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, ID, IN, MN, NC, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TX, VA, WI, WY and OUS: 81 countries.",
      "openfda": {
        "k_number": [
          "K131037",
          "K961487",
          "K130020",
          "K203227",
          "K230790",
          "K880678",
          "K873986",
          "K873872",
          "K033234",
          "K221990",
          "K003178",
          "K952283",
          "K932409",
          "K013678",
          "K882896",
          "K884207",
          "K063720",
          "K970894",
          "K983424",
          "K882192",
          "K941983",
          "K994085",
          "K913236",
          "K955707",
          "K192547",
          "K230937",
          "K961792",
          "K862108",
          "K945331",
          "K892654",
          "K990222",
          "K063754",
          "K072500",
          "K000844",
          "K893577",
          "K891096",
          "K941090",
          "K974368",
          "K022681",
          "K991532",
          "K911796",
          "K002148",
          "K133002",
          "K042676",
          "K991515",
          "K893873",
          "K013857",
          "K031052",
          "K950307",
          "K974425",
          "K192790",
          "K060548",
          "K961351",
          "K970387",
          "K170317",
          "K891095",
          "K922073",
          "K080094",
          "K003696",
          "K884430",
          "K883235",
          "K883148",
          "K973825",
          "K163418",
          "K974512",
          "K893953",
          "K212221",
          "K233581",
          "K882895",
          "K223690",
          "K200210",
          "K022680"
        ],
        "registration_number": [
          "3026478115",
          "3005333358",
          "3016244760",
          "3004635103",
          "3017125176",
          "9614698",
          "3042471840",
          "3011522054",
          "1319681",
          "3004434309",
          "3023268435",
          "3010825766",
          "3005643513",
          "2250051",
          "3012963943",
          "3007111389",
          "9610240",
          "3002637618",
          "2032682",
          "3023322455",
          "3026478116",
          "3016438761",
          "3002642396",
          "2122870",
          "1649661",
          "1415939",
          "3008344661",
          "2517506",
          "1036362",
          "2020726",
          "3005094123",
          "2432235",
          "3002809144",
          "3006198300",
          "2246703",
          "3002806944",
          "2032839",
          "1219913",
          "3017019647",
          "3004192065",
          "9680746",
          "3006479639",
          "3007606081",
          "3000308930",
          "9610126"
        ],
        "fei_number": [
          "3026478115",
          "3005333358",
          "3016244760",
          "3004635103",
          "3017125176",
          "3002806559",
          "3042471840",
          "3011522054",
          "1000206808",
          "3004434309",
          "3023268435",
          "3010825766",
          "3005643513",
          "2250051",
          "3012963943",
          "3007111389",
          "3002637618",
          "3004185580",
          "3001451797",
          "1000136573",
          "3023322455",
          "3026478116",
          "3016438761",
          "3002642396",
          "2122870",
          "3002808382",
          "1415939",
          "3008344661",
          "2517506",
          "1036362",
          "3002808212",
          "3003952975",
          "2020726",
          "3005094123",
          "2432235",
          "3002809144",
          "3006198300",
          "2246703",
          "3002806944",
          "1219913",
          "3017019647",
          "3004192065",
          "3006479639",
          "3007606081",
          "3000308930"
        ],
        "device_name": "System, Test, Human Chorionic Gonadotropin",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1155",
        "device_class": "2"
      }
    }
  ]
}