{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "142255",
      "product_res_number": "Z-0636-2016",
      "event_date_initiated": "2015-12-08",
      "event_date_posted": "2016-01-12",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-08-04",
      "res_event_number": "72808",
      "product_code": "JJJ",
      "product_description": "Perkin Elmer WIZARD2 5-detector, 1000 samples\nProduct Code: 2470-0150, 3470-0150\nThe Wizard gamma counter is intended to detect and count gamma radiation emitted by clinical samples",
      "code_info": "Serial Numbers: DG04129084 DG12118776 DG04117773 DG05106408",
      "firm_fei_number": "3006159931",
      "recalling_firm": "Perkinelmer",
      "address_1": "940 Winter Street",
      "city": "Waltham",
      "state": "MA",
      "postal_code": "02451",
      "reason_for_recall": "The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect.  The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed.  If the error is undetected, the Gamma Counter may produce erroneous results.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Perkin Elmer sent an Urgent Medical Device Correction letter dated December 7, 2015 to affected customers.  The letter identified the affected products, problems and actions to be taken.  Customers were instructed to destroy all affected products in their possession. Customers were asked to complete the\nenclosed Correction Response Form and return it by scan and e-mail to QMresponse.SG@perkinelmer.com . Corrected barcode labels ID #023 will be provided upon request and return of the completed Correction Response Form to PerkinElmer.  For further information contact your local PerkinElmer representatives..",
      "product_quantity": "4 units",
      "distribution_pattern": "Worldwide Distribution - US Nationwide and the countries of \nARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GREECE, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, MYANMAR, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, and THAILAND.",
      "openfda": {
        "k_number": [
          "K852434",
          "K822293",
          "K813472",
          "K830751",
          "K832734",
          "K870115",
          "K884091",
          "K771180",
          "K920559",
          "K946387",
          "K841352",
          "K801264",
          "K790961",
          "K780383",
          "K851164",
          "K810345",
          "K760900",
          "K800388",
          "K821892",
          "K770740",
          "K830365",
          "K884269",
          "K770572",
          "K760470",
          "K800601",
          "K832210",
          "K834508",
          "K832002",
          "K780344",
          "K801245",
          "K851689",
          "K771613",
          "K872430",
          "K862206",
          "K771614",
          "K832735",
          "K780341",
          "K780790",
          "K900087",
          "K760424",
          "K820376",
          "K832209",
          "K962762",
          "K823240",
          "K771369",
          "K872429",
          "K760828",
          "K894902",
          "K896202",
          "K771129",
          "K874094",
          "K772099",
          "K802578",
          "K770088",
          "K761214",
          "K801263",
          "K780179",
          "K820137",
          "K842902",
          "K821494",
          "K832736",
          "K790905",
          "K771612"
        ],
        "device_name": "Counter (Beta, Gamma) For Clinical Use",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.2320",
        "device_class": "1",
        "registration_number": [
          "",
          "3004049804",
          "1219913",
          "3003529145"
        ],
        "fei_number": [
          "",
          "3004049804",
          "1219913",
          "3003857949"
        ]
      }
    }
  ]
}