{
  "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": 1
    }
  },
  "results": [
    {
      "cfres_id": "29333",
      "product_res_number": "Z-0028-04",
      "event_date_initiated": "2003-09-02",
      "event_date_posted": "2003-10-15",
      "recall_status": "Terminated",
      "event_date_terminated": "2003-12-10",
      "res_event_number": "27164",
      "product_code": "LNN",
      "product_description": "Roche/Hitachi brand lactate reagent for the quantitative determination of L-lactate in plasma, cerebrospinal fluid or whole blood.  Catalog # 1822837.",
      "code_info": "All lots of reagent when used manually or on the Roche/Hitachi 902, 911, 912, 917 or Modular Analytics P module analyzers.",
      "firm_fei_number": "1823260",
      "recalling_firm": "Roche Diagnostics Corp.",
      "address_1": "9115 Hague Road",
      "city": "Indianapolis",
      "state": "IN",
      "postal_code": "46250-0457",
      "additional_info_contact": "800-428-2336",
      "reason_for_recall": "Patient samples with very high lactate values may falsely be reported as within the normal range without the instrument giving a warning flag to the technician.",
      "root_cause_description": "Other",
      "action": "Recall letters were sent to U.S. customers on 9/2/03 instructing them not to run lactate with these analyzers.  An update notification letter was sent on or about 9/18/03 telling customers to discontinue use of the product for manual lactate determinations.",
      "product_quantity": "21958",
      "distribution_pattern": "United States, Canada and Germany",
      "openfda": {
        "k_number": [
          "K901881",
          "K932342"
        ]
      }
    }
  ]
}