{
  "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": 4
    }
  },
  "results": [
    {
      "cfres_id": "48393",
      "product_res_number": "Z-0078-2007",
      "event_date_initiated": "2006-08-21",
      "event_date_posted": "2006-10-27",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-06-14",
      "res_event_number": "36309",
      "product_code": "GMZ",
      "product_description": "HardyCHROM 0157, Catalogue Number: G305, Lot Numbers: 06192 & 06235, Packaged: 10 plates per sleeve, Hardy Diagnostics, Santa Maria, CA 93455",
      "code_info": "Lot numbers: 06192 (exp: 10/09/2006) and 06235 (exp:10/22/2006)",
      "firm_fei_number": "2022807",
      "recalling_firm": "Hardy Media Inc Dba Hardy Diag",
      "address_1": "1430 W Mccoy Ln",
      "city": "Santa Maria",
      "state": "CA",
      "postal_code": "93455-1005",
      "additional_info_contact": "Kelley J. Day\n800-266-2222 Ext. 5695",
      "reason_for_recall": "Performance failure;  the product is failing to show pigment development for E. coli 0157.",
      "root_cause_description": "Other",
      "action": "Customers were first notified by phone on 8/21/06. Then all customers are faxed and mailed a signed recall letter via first class mail. All customers will be contacted, calling every few days until all have responded and all product reconciliation is made.\n\nA second recall notice was mailed 09/25/06 to include the original lot (#06192) plus an additional lot (#06235).\n  \nCustomers will be instructed to dispose of all remaining inventory. Hardy Diagnostics will credit or replace their purchase.",
      "product_quantity": "850 plates",
      "distribution_pattern": "Nationwide Distribution, including the states of  CA, IL, ME, NV, OK, TX, UT, WA & WY",
      "openfda": {
        "k_number": [
          "K944421",
          "K061889",
          "K942705",
          "K121364",
          "K023599",
          "K973457",
          "K971663",
          "K222829",
          "K972156",
          "K884513",
          "K121411",
          "K990263",
          "K062546",
          "K980507"
        ],
        "device_name": "Antigens, All Types, Escherichia Coli",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3255",
        "device_class": "1",
        "registration_number": [
          "1122855",
          "2182595",
          "3005360469",
          "3003750284",
          "8010383",
          "3009935129",
          "1524213",
          "9611882",
          "9610140",
          "3014684020"
        ],
        "fei_number": [
          "3002808078",
          "2182595",
          "3003750284",
          "3005670738",
          "1000123404",
          "1000354384",
          "3009935129",
          "1524213",
          "3014684020",
          "3002806906"
        ]
      }
    }
  ]
}