{
  "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": "49521",
      "product_res_number": "Z-0356-2007",
      "event_date_initiated": "2006-12-15",
      "event_date_posted": "2007-01-17",
      "recall_status": "Terminated",
      "event_date_terminated": "2008-04-23",
      "res_event_number": "36887",
      "product_code": "CFN",
      "k_numbers": [
        "K982382"
      ],
      "product_description": "Roche IGGT COBAS INTEGRA Immunoglobulin G (Turbidimetric); Catalog no. 20766631322. in vitro diagnostic.",
      "code_info": "Lots:  66160001; exp. 12/31/06; 66395101, exp. 2/28/07; 67306401, exp. 1/31/08; 66954901, exp. 5/31/07; 67589901, exp. 4/30/08 and 68049501, exp. 10/31/08.",
      "firm_fei_number": "1823260",
      "recalling_firm": "Roche Diagnostics Corp.",
      "address_1": "9115 Hague Rd",
      "city": "Indianapolis",
      "state": "IN",
      "postal_code": "46256-1025",
      "additional_info_contact": "800-428-2336",
      "reason_for_recall": "Falsely elevated IGGT results may be reported because the R2 reagent of the Tina-quant Gen.2 albumin assay has a carryover effect on the Immunoglobulin G (turbidimetric) assay on the COBAS INTEGRA 700 and 800 analyzers and the R1 reagent of the Tina-quant Hemoglobin A1c assay has a carryover effect on the Immunoglobulin G (turbidimetric) assay on the COBAS INTEGRA 800 analyzer.",
      "root_cause_description": "Other",
      "action": "Device correction letters dated 12/15/06 instructing users to perform an extra wash cycle between applications when using both the ALBT2 and IGGT cassettes on the COBAS INTEGRA 700 and 800 analyzers.  The recall was extended to via device correction letters dated 2/28/07 instructing users to perform an extra wash cycle between applications when using both the A1C2 and IGGT cassettes on the COBAS INTEGRA 800 analyzer.",
      "product_quantity": "18,905",
      "distribution_pattern": "Nationwide.",
      "openfda": {
        "k_number": [
          "K042475",
          "K923070",
          "K191985",
          "K191635",
          "K061338",
          "K090594",
          "K191465",
          "K082823",
          "K982100",
          "K933973",
          "K082129",
          "K880356",
          "K192116",
          "K781655",
          "K000701",
          "K073489",
          "K933971",
          "K162208",
          "K190686",
          "K993924",
          "K042735",
          "K083445",
          "K771226",
          "K081827",
          "K103824",
          "K864342",
          "K933970",
          "K120750",
          "K993547",
          "K042152",
          "K221114",
          "K130122",
          "K781656",
          "K061845",
          "K781654",
          "K120901",
          "K100588",
          "K032014",
          "K981784",
          "K150526",
          "K081161",
          "K073561",
          "K012291",
          "K183151",
          "K012292",
          "K072889",
          "K073487",
          "K120749",
          "K142735",
          "K233663",
          "K073490",
          "K982382",
          "K860894",
          "K871343",
          "K012295",
          "K993549",
          "K981912",
          "K113823",
          "K090920",
          "K012296",
          "K022083"
        ],
        "registration_number": [
          "2050012",
          "3004493545",
          "3012963943",
          "3011989923",
          "9614373",
          "1319681",
          "9680746",
          "1319808",
          "2050010",
          "9610126",
          "2250051",
          "3000148879",
          "3003795116",
          "3012471076",
          "3002642396",
          "2432235",
          "3000308930",
          "3006198300",
          "9610529",
          "9610806"
        ],
        "fei_number": [
          "2050012",
          "3004493545",
          "3012963943",
          "3011989923",
          "3002808340",
          "2050010",
          "3002806560",
          "2250051",
          "3000148879",
          "3002806559",
          "3003795116",
          "3012471076",
          "1000305841",
          "1000136573",
          "3002642396",
          "3001644026",
          "1000206808",
          "2432235",
          "3000308930",
          "3006198300"
        ],
        "device_name": "Method, Nephelometric, Immunoglobulins (G, A, M)",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5510",
        "device_class": "2"
      }
    }
  ]
}