{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "74791",
      "product_res_number": "Z-0669-2009",
      "event_date_initiated": "2008-09-22",
      "event_date_posted": "2009-01-28",
      "recall_status": "Terminated",
      "event_date_terminated": "2010-07-06",
      "res_event_number": "50129",
      "product_code": "JTZ",
      "product_description": "HARDY DIAGNOSTIC McFarland Standard 0.5; in vitro diagnostic, glass vial, one vial per box",
      "code_info": "Model Number: Hardy = MSO5; Lot number 08182; Expiration date: 10/28/08",
      "firm_fei_number": "1000515493",
      "recalling_firm": "Trek Diagnostic Systems",
      "address_1": "982 Keynote Cir Ste 6 982 Keynote Cir",
      "address_2": "Ste 6",
      "city": "Cleveland",
      "state": "OH",
      "postal_code": "44131-1873",
      "additional_info_contact": "Teresa Anacker\n608-837-3788 Ext. 224",
      "reason_for_recall": "Incorrect result:  The absorbance has changed as the standards have aged; the standards' turbidity has become denser. The recalled lot is now reading 0.15 ABS @ 625 nm. TREK'S internal specification and the manufacturer's (Hardy Diagnostics) specification is 0.08 - 0.10 ABS @625 nm. CLSI specifies 0.08 - 0.13 ABS @ 625 nm.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On 9/22/2008 TREK Diagnostic sent a recall notification letter to their customers advising them of the problem with the product.  They instructed their customers to inventory their stock for any remaining recall lot and immediately destroy.",
      "product_quantity": "4 vials",
      "distribution_pattern": "USA distribution in OH and IL.",
      "openfda": {
        "k_number": [
          "K811136",
          "K833506",
          "K811608",
          "K790369",
          "K863821",
          "K851589",
          "K854451",
          "K833861",
          "K850553",
          "K850715",
          "K821428",
          "K853238",
          "K791815",
          "K820846",
          "K791818",
          "K850291",
          "K820794",
          "K840969",
          "K832243",
          "K882351",
          "K861301",
          "K802498",
          "K800979",
          "K864246",
          "K820793",
          "K780958",
          "K801901",
          "K841834",
          "K840066",
          "K841755",
          "K873268",
          "K791624",
          "K821430",
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          "K811471",
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          "K841213",
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          "K960420",
          "K841560",
          "K851518",
          "K850843",
          "K871097",
          "K864248",
          "K811646",
          "K850731",
          "K791413",
          "K812581",
          "K945911",
          "K792481",
          "K941985",
          "K820792",
          "K821607",
          "K822119",
          "K864245",
          "K864247",
          "K854521",
          "K811049",
          "K851225",
          "K870649",
          "K780959",
          "K880105",
          "K821429",
          "K963036",
          "K830060",
          "K842854",
          "K132491",
          "K791485",
          "K841138",
          "K802957"
        ],
        "device_name": "Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.1700",
        "device_class": "2",
        "registration_number": [
          "1530126",
          "1119779",
          "8021914",
          "3009547954",
          "1924669",
          "2919016",
          "1120041",
          "2022807",
          "8010096",
          "1111096"
        ],
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          "3006224287",
          "1119779",
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          "1000515493",
          "1924669",
          "3002806332",
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          "1120041",
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          "1111096"
        ]
      }
    }
  ]
}