{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Beaumont",
      "address_1": "1530 Lindbergh Dr",
      "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.",
      "address_2": "",
      "product_quantity": "328/50-pouch kits",
      "code_info": "Kit lots 2-17-5651, exp. 8/31/2018,  and 3-17-5651, 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.",
      "center_classification_date": "20190705",
      "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.    There was no foreign/military/government distribution.",
      "state": "TX",
      "product_description": "ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use.  The firm name on the label is Helena Laboratories, Beaumont, TX.",
      "report_date": "20190717",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Helena Laboratories, Corp.",
      "recall_number": "Z-1950-2019",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "product_type": "Devices",
      "event_id": "83088",
      "more_code_info": "",
      "recall_initiation_date": "20180808",
      "postal_code": "77707-4131",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Ongoing"
    }
  ]
}