{
  "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": "73245",
      "product_res_number": "Z-0173-2009",
      "event_date_initiated": "2008-08-02",
      "event_date_posted": "2008-10-24",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-08-13",
      "res_event_number": "49393",
      "product_code": "MRG",
      "k_numbers": [
        "K021163"
      ],
      "product_description": "IDS 25-Hydroxy Vitamin D EIA Enzymeimmunoassay for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated metabolites in serum or plasma.  Ref: AC-57F1  Lot 60897  Exp 2009-08;  Immunodiagnostic Systems Ltd, Unit 10, Boldon Business Park, Boldon, Tyne & Wear, NE35.  9PD, UK.    Enzymeimmunoassay for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated metabolites in serum or plasma",
      "code_info": "Lot Code #60897",
      "firm_fei_number": "3004046329",
      "recalling_firm": "Immunodiagnostics Systems Inc",
      "address_1": "17029 E Enterprise Dr Ste 1 17029 E Enterprise Dr",
      "address_2": "Ste 1",
      "city": "Fountain Hills",
      "state": "AZ",
      "postal_code": "85268",
      "reason_for_recall": "A small number of customers have experienced low absorbance values when using kits from this batch.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "All customers who received 25-Hydroxy Vitamin D EIA lot # 60897 were contacted by mail.  Customers were instructed to sign a confirming document for having received the notification letter and return via fax.  Customers are requested to contact Immunodiagnostic System Inc's office if they have any kits of 60897 remaining in stock. Rather than replacing only the biotin buffer as stated in the letter dated August 2, 2008, Immunodiagnostic Systems Inc. will replace the kit per the letter dated August 8, 2008.  Contact Immunodiagnostic System Inc. at 1-480-836-7435 for assistance.",
      "product_quantity": "691 kits",
      "distribution_pattern": "Nationwide",
      "openfda": {
        "k_number": [
          "K142362",
          "K162754",
          "K102432",
          "K153375",
          "K110619",
          "K223503",
          "K210901",
          "K221817",
          "K051110",
          "K112725",
          "K200509",
          "K122420",
          "K142373",
          "K191499",
          "K071480",
          "K140554",
          "K141114",
          "K142351",
          "K021163",
          "K162840",
          "K172992",
          "K123364",
          "K232587",
          "K091849",
          "K150270",
          "K132492",
          "K161831",
          "K121608",
          "K032844",
          "K953567",
          "K133410",
          "K141463",
          "K042519",
          "K014030",
          "K180577",
          "K110586",
          "K123131",
          "K123253",
          "K162298",
          "K072536",
          "K123983",
          "K991998",
          "K133156",
          "K113546",
          "K153361",
          "K123660"
        ],
        "registration_number": [
          "3002637618",
          "2032087",
          "3014862385",
          "2122870",
          "3009518015",
          "9612316",
          "3007118747",
          "9615777",
          "2245285",
          "2029372",
          "3009092698",
          "2182595",
          "3005529799",
          "3002809144",
          "1222302",
          "2432235",
          "3010610113",
          "3009335633",
          "3005360469",
          "3005094123",
          "3021841051",
          "8021924",
          "3032705",
          "2032900",
          "9610126",
          "3022178699",
          "8023018",
          "3012963943",
          "3007349751",
          "3011989923",
          "3005174594",
          "1219913",
          "8031673",
          "3010324880",
          "1319681",
          "3002642396",
          "3007111389",
          "3000308930",
          "2250051",
          "3002800697",
          "2020726",
          "3005333358",
          "2244821",
          "2032839",
          "1063851",
          "9680746",
          "2032682",
          "3003268355",
          "2517506",
          "2915274",
          "3007361513"
        ],
        "fei_number": [
          "3002637618",
          "3002485711",
          "3014862385",
          "3002808328",
          "2122870",
          "3009518015",
          "3007118747",
          "2967",
          "2245285",
          "3002807272",
          "3009092698",
          "2182595",
          "2915274",
          "3005529799",
          "1000442352",
          "3002809144",
          "2432235",
          "3010610113",
          "3003355251",
          "3004185580",
          "3009335633",
          "3005094123",
          "3021841051",
          "3022178699",
          "1000206808",
          "3012963943",
          "3007349751",
          "3011989923",
          "3005174594",
          "1219913",
          "3007111389",
          "3010324880",
          "3003952975",
          "3002642396",
          "2244821",
          "3000308930",
          "2250051",
          "3002800697",
          "2020726",
          "3005333358",
          "1000121039",
          "3005670738",
          "3003268355",
          "1000136573",
          "3007034602",
          "2517506",
          "3002701146",
          "3002806559",
          "3004445302",
          "1000306617",
          "3007361513"
        ],
        "device_name": "System, Test, Vitamin D",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1825",
        "device_class": "2"
      }
    }
  ]
}