{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "175320",
      "product_res_number": "Z-0043-2020",
      "event_date_initiated": "2019-07-23",
      "event_date_created": "2019-10-04",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-06-08",
      "res_event_number": "83467",
      "product_code": "LEH",
      "k_numbers": [
        "K152245"
      ],
      "product_description": "Online TDM Vancomycin Gen.3 ( 200 tests)\nCatalog # 06779344190\nAnalyzer/Module: cobas c 311 and cobas c 501/502",
      "code_info": "All Lots",
      "firm_fei_number": "1823260",
      "recalling_firm": "Roche Diagnostics Operations, Inc.",
      "address_1": "9115 Hague Rd",
      "city": "Indianapolis",
      "state": "IN",
      "postal_code": "46256-1025",
      "additional_info_contact": "Roche Support Network Customer Support Center\n800-428-2336",
      "reason_for_recall": "Inaccurately Low Sample Results",
      "root_cause_description": "Under Investigation by firm",
      "action": "1. Consignees will be provided instruction to download the updated e-barcode either from the cobas link or from the cobas e-library when available.\n\n2. If analyzers cobas link is not connected to the Roche network, a future version of the cobas e-library CD will contain the revised e-barcodes. Download the e-barcode when available.\n\n3. If analyzers cobas link is not connected to the Roche network and they require the updated VANC3 application e-barcode before the cobas e-library CD is available, they will be instructed to contact the Roche Support Network Customer Support Center at 1-800-428-2336 to request a Field Application Specialist to provide the VANC3 updated application.\n\n4. Calibrate and run quality controls (QC) before running samples.\n\n5.Complete all sections of the enclosed fax form.\n\nPlease contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.",
      "product_quantity": "33979 units",
      "distribution_pattern": "AK\nAL\nAR\nAZ\nCA\nCO\nCT\nDC\nDE\nFL\nGA\nGU\nHI\nIA\nID\nIL\nIN\nKS\nKY\nLA\nMA\nMD\nME\nMI\nMN\nMO\nMS\nMT\nNC\nND\nNE\nNH\nNJ\nNM\nNV\nNY\nOH\nOK\nOR\nPA\nPR\nRI\nSC\nSD\nTN\nTX\nUT\nVA\nVT\nWA\nWI\nWV\nWY",
      "openfda": {
        "k_number": [
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          "K874438",
          "K953528",
          "K951059",
          "K901759",
          "K945125",
          "K822308",
          "K020692",
          "K013076",
          "K043386",
          "K964587",
          "K821136",
          "K983280",
          "K955716",
          "K123947",
          "K152245",
          "K050419",
          "K963267",
          "K060586",
          "K924957",
          "K900708",
          "K955851",
          "K032811",
          "K072036",
          "K892900",
          "K160202",
          "K222439",
          "K063045",
          "K813218",
          "K940595",
          "K872579"
        ],
        "registration_number": [
          "3003795116",
          "3033967997",
          "1319808",
          "9610529",
          "3010939897",
          "3005755244",
          "3002809144",
          "2432235",
          "3010825766",
          "2050012",
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          "2050010",
          "3012963943",
          "3003561301",
          "1219913",
          "1319681",
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          "2250051",
          "3005333358",
          "3004493545",
          "2517506",
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          "3002806944",
          "3006198300"
        ],
        "fei_number": [
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          "3003795116",
          "3033967997",
          "1000305841",
          "3010939897",
          "3005755244",
          "3007019572",
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          "2050012",
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          "3012963943",
          "3003561301",
          "1219913",
          "3002642396",
          "3000308930",
          "2250051",
          "3005333358",
          "3002806560",
          "3004493545",
          "1000136573",
          "2517506",
          "1317202",
          "3002806944",
          "3006198300",
          "3002806559"
        ],
        "device_name": "Radioimmunoassay, Vancomycin",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3950",
        "device_class": "2"
      }
    }
  ]
}