{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "cfres_id": "170822",
      "product_res_number": "Z-1237-2019",
      "event_date_initiated": "2019-01-10",
      "event_date_created": "2019-04-27",
      "recall_status": "Open, Classified",
      "res_event_number": "82064",
      "product_code": "JHJ",
      "k_numbers": [
        "K862044"
      ],
      "product_description": "DELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG)\nProduct Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum.",
      "code_info": "Kit Lot Numbers: 664891, 666471, 666604 Pack Lot Numbers: 1066489101, 1066647101,1066660401 UDI:  (01)06438147009176(17)190430(10)664891 (01)06438147009176(17)190430(10)666471 (01)06438147009176(17)190430(10)666604",
      "firm_fei_number": "3002808498",
      "recalling_firm": "PerkinElmer Life and Analytical Sciences, Wallac, OY",
      "address_1": "Mustionkatu 6 6 mustionkatu",
      "address_2": "P.O. Box 10",
      "city": "Turku",
      "country": "Finland",
      "reason_for_recall": "hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Perkin Elmer initiated  notification on January 10, 2018. The Recall Letter delivered to the end customer by email facilitated through the PerkinElmer Technical Support Group. PerkinElmer requires customers to:\nInspect DELFIA / AutoDELFIA hCG kit inventory for the affected lots.\nReview your QC follow-up of the AutoDELFIA hCG assay for potential decrease in the control concentrations.\nIf the control values are within your established acceptance range it is safe to report the results\nTo avoid unnecessary repeat testing of samples, if the control values are out of the acceptance range discontinue use of the DELFIA / AutoDELFIA hCG kit lot and dispose the remaining kits of the lot.\nComplete the Response Form with the quantity of affected DELFIA / AutoDELFIA hCG kits you have disposed from your inventory",
      "product_quantity": "31 kits (10 in US, 21 in ROW)",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution. and countries of  Austria, Bolivia, UK,  Switzerland,Thailand, Finland.",
      "openfda": {
        "k_number": [
          "K832867",
          "K831775",
          "K863741",
          "K812789",
          "K831339",
          "K812261",
          "K812967",
          "K841853",
          "K840738",
          "K831361",
          "K802435",
          "K802450",
          "K823682",
          "K833156",
          "K792657",
          "K831155",
          "K842314",
          "K800055",
          "K830156",
          "K771514",
          "K812924",
          "K832640",
          "K871294",
          "K832557",
          "K832879",
          "K791609",
          "K862044",
          "K790267",
          "K842544",
          "K860945",
          "K844914",
          "K821676",
          "K844346",
          "K821552",
          "K853247",
          "K880328",
          "K802334",
          "K810581",
          "K831468",
          "K791309",
          "K861703",
          "K926112",
          "K790898",
          "K782063",
          "K972606",
          "K831366",
          "K852286",
          "K854670",
          "K921968",
          "K802343",
          "K812334",
          "K811940",
          "K840833",
          "K920716",
          "K831383",
          "K831535",
          "K790002",
          "K790734",
          "K802660",
          "K861211",
          "K831466",
          "K862083",
          "K832527",
          "K832599",
          "K880163",
          "K844347",
          "K874638",
          "K831180",
          "K802421",
          "K833137",
          "K791706",
          "K852066",
          "K821387",
          "K863198",
          "K861212",
          "K930609",
          "K935863",
          "K832918",
          "K802974",
          "K840650",
          "K812788",
          "K842181",
          "K792027",
          "K910946",
          "K834346",
          "K881435",
          "K832473",
          "K833504",
          "K875262",
          "K811941",
          "K850604",
          "K782166",
          "K842110",
          "K880478",
          "K781049",
          "K831125"
        ],
        "device_name": "Agglutination Method, Human Chorionic Gonadotropin",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1155",
        "device_class": "2",
        "registration_number": [
          "1220477",
          "8043909"
        ],
        "fei_number": [
          "1220477",
          "3002808498"
        ]
      }
    }
  ]
}