{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Pomona",
      "state": "CA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80096",
      "recalling_firm": "Alere San Diego Inc. DBA Immunalysis Corporation",
      "address_1": "829 Towne Center Dr",
      "address_2": "N/A",
      "postal_code": "91767-5901",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Distribution to the states of : CA, CO, CT, FL, LA, MD, NC, NJ, OH, OK, TN, TX, WI, and WV",
      "recall_number": "Z-2140-2018",
      "product_description": "lmmunalysis EDDP Urine Control Set 1    The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as control materials in the ammonolysis EDDP Specific Urine Enzyme Immunoassay, which has a cutoff of 100 ng/ml. This test provides only a preliminary analytical test result and a more specific alternate chemical method, such as Gas Chromatography/Mass Spectrometry or Liquid Chromatography/Tandem Mass Spectrometry, must be used to obtain a confirmed analytical result.",
      "product_quantity": "37 kits",
      "reason_for_recall": "The High (125 ng/ml) Control does not meet specification - it has been confirmed to produce values below 100 ng/mL when run on validated clinical chemistry analyzers, which is below the 100 ng/mL cutoff of the EDDP Specific Urine Enzyme Immunoassay with which this control is utilized.",
      "recall_initiation_date": "20171128",
      "center_classification_date": "20180608",
      "termination_date": "20210129",
      "report_date": "20180620",
      "code_info": "Part Number: 3006-5, Lot Number: EK16135"
    }
  ]
}