{
  "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": 2
    }
  },
  "results": [
    {
      "cfres_id": "173480",
      "product_res_number": "Z-1949-2019",
      "event_date_initiated": "2018-08-08",
      "event_date_created": "2019-07-05",
      "recall_status": "Open, Classified",
      "res_event_number": "83088",
      "product_code": "KHE",
      "k_numbers": [
        "K882799"
      ],
      "product_description": "ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use.  The firm name on the label is Helena Laboratories, Beaumont, TX.",
      "code_info": "Kit lots 1-17-5650, exp. 8/31/2018,  and 2-17-5650, exp. 9/30/2018.  These kit lots contain ColoCARE pad lot numbers 1-17-551039, exp. 8/31/2018, and 2-17-551039, exp. 9/30/2018.",
      "firm_fei_number": "1618982",
      "recalling_firm": "Helena Laboratories, Corp.",
      "address_1": "1530 Lindbergh Dr",
      "city": "Beaumont",
      "state": "TX",
      "postal_code": "77707-4131",
      "additional_info_contact": "Dr. Jessica Jones Hanka\n409-842-3714 Ext. 1177",
      "reason_for_recall": "The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "The recalling firm made notifications beginning 8/8/2018 via phone and letter delivered via email.   Customers were to dispose of the product.",
      "product_quantity": "27/250 pouch kits",
      "distribution_pattern": "Distribution was made to AK, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, MS, MT, NC, ND, NE, NV, NY, OH, OK, PA, SD, TN, TX, VA, WA, and WY.\n\nThere was no foreign/military/government distribution.",
      "openfda": {
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          "K980671",
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          "K871143",
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        "device_name": "Reagent, Occult Blood",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.6550",
        "device_class": "2",
        "registration_number": [
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