{
  "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": [
    {
      "status": "Terminated",
      "city": "Santa Maria",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85412",
      "recalling_firm": "Hardy Diagnostics",
      "address_1": "1430 W McCoy Ln",
      "address_2": "N/A",
      "postal_code": "93455-1005",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Distribution in the states of WI, CA, WA, IA, MT, UT, AZ, WY, KS, MO, OR, TX, VI, including PR and Guam.    OUS: British Virgin Islands, Kenya,",
      "recall_number": "Z-2298-2020",
      "product_description": "HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium for the qualitative direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA). Not intended to diagnose infection of guide therapy. Further testing required for susceptibility or typing.     Container Type: 15 x 100mm monoplate  Packaged: 10 plates/sleeve  STORAGE: 2-8 degree C on receipt, LIGHT SENSITIVE     IVD UDI: (01)08165760201400 (10)447694 (17)191206",
      "product_quantity": "3,580 ea (358 kits, pack of 10 in each)",
      "reason_for_recall": "False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited.",
      "recall_initiation_date": "20191114",
      "center_classification_date": "20200608",
      "termination_date": "20210428",
      "report_date": "20200617",
      "code_info": "Catalogue no.: G307, Lot number 447694 HDx, UDI # 00816576020140"
    }
  ]
}