{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Indianapolis",
      "address_1": "9115 Hague Rd",
      "reason_for_recall": "Roche Diagnostics Operations, Inc. has issued a voluntary recall for the Online TDM Vancomycin assay on the cobas c 311/501/502 analyzers and the Modular Analytics P module due method sheets that state an incorrect method comparison against the COBAS INTEGRA 800 analyzer.",
      "address_2": "",
      "product_quantity": "53,897 Units distributed",
      "code_info": "04491050190 \u0013 ONLINE TDM Vancomycin 100 tests  05108420190 \u0013 ONLINE TDM Vancomycin 200 tests  04642490190 \u0013 Hitachi Vancomycin (Modular P)  04642481190 \u0013 Hitachi Vancomycin (917, MOD P)",
      "center_classification_date": "20160801",
      "distribution_pattern": "Nationwide Distribution to the states of :  AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA,  PR, RI, SC, SD, TN,TX, UT, VA, VT, WA, WI, WV, WY    Foreign:None    VA/DOD: See list below",
      "state": "IN",
      "product_description": "ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Vancomycin (Modular P); Hitachi Vancomycin (917, MOD P)    The ONLINE TDM Vancomycin assay is for the quantitative determination of Vancomycin in human serum or plasma on Roche automated clinical chemistry analyzers.",
      "report_date": "20160810",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Roche Diagnostics Operations, Inc.",
      "recall_number": "Z-2304-2016",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "74312",
      "termination_date": "20170323",
      "more_code_info": "",
      "recall_initiation_date": "20160526",
      "postal_code": "46256-1025",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}