{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "210237",
      "product_res_number": "Z-0258-2025",
      "event_date_initiated": "2024-09-13",
      "event_date_posted": "2024-10-29",
      "recall_status": "Open, Classified",
      "res_event_number": "95429",
      "product_code": "JLX",
      "product_description": "17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma \nModel/Catalog Number: EIA-1292",
      "code_info": "Lot Code: 04048474012927 (DRG Instruments GmbH)\nlots: 22K024 and 22K034",
      "firm_fei_number": "2245285",
      "recalling_firm": "DRG International, Inc.",
      "address_1": "841 Mountain Ave",
      "city": "Springfield",
      "state": "NJ",
      "postal_code": "07081-3437",
      "additional_info_contact": "SAME\n862-227-2316",
      "reason_for_recall": "The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match the acceptance range information on the High and Low Control Component labels. Due to the defect, the device failed to provide results, which may result in a delay in obtaining test results and a remote chance of an adverse health risk.",
      "root_cause_description": "Process change control",
      "action": "DRG issued Urgent Field Safety Notification on 9/17/24 via email. Letter states reason for recall, health risk and action to take:\nPlease check your inventory for the respective lot and ensure that the proper acceptance ranges provided below are used to validate the assay.\nImmediately reply to email: qa@drg-international.com to confirm this notice and your compliance.",
      "product_quantity": "504 units",
      "distribution_pattern": "AZ, CA,  NH\nForeign:\nAustria\nBelgium\nGeorgia\nGermany\nGreece\nIndia\nIrak\nItaly\nNetherlands\nPoland\nRomania\nRussia\nSingapore\nSpain\nTunesia\nVietnam",
      "openfda": {
        "k_number": [
          "K940233",
          "K060452",
          "K885198",
          "K050960",
          "K943148",
          "K771729",
          "K874782",
          "K100682",
          "K042424",
          "K911839",
          "K973350",
          "K912026",
          "K081922",
          "K860335",
          "K062534",
          "K834246",
          "K934178",
          "K042425",
          "K894265"
        ],
        "registration_number": [
          "2245285",
          "3007118747",
          "9710337",
          "9612316",
          "3003559191",
          "2029372",
          "9610126",
          "2020726",
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          "3007361513",
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          "2133982",
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          "3005542422",
          "8010132",
          "3009335633",
          "3022178699",
          "3002800697",
          "3005529799"
        ],
        "fei_number": [
          "3004185580",
          "2245285",
          "3002808328",
          "3007118747",
          "3002676602",
          "3003559191",
          "2967",
          "2020726",
          "3007361513",
          "3003741796",
          "3002806559",
          "3050015",
          "1000121039",
          "1000306617",
          "3002806808",
          "3005542422",
          "3000717645",
          "3002808498",
          "3009335633",
          "3022178699",
          "3002800697",
          "3005529799"
        ],
        "device_name": "Radioimmunoassay, 17-Hydroxyprogesterone",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1395",
        "device_class": "1"
      }
    }
  ]
}