{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "54521",
      "product_res_number": "Z-0459-2008",
      "event_date_initiated": "2007-08-30",
      "event_date_posted": "2007-12-12",
      "recall_status": "Terminated",
      "event_date_terminated": "2008-09-08",
      "res_event_number": "38897",
      "product_code": "JJF",
      "k_numbers": [
        "K033734"
      ],
      "product_description": "Roche Diagnostics LightCycler Capillaries (100uL) for use in conjunction with the LightCycler analyzers; Catalog #: 03337090001, plus any capillaries received at the time of installation of the LightCycler instruments or systems **, Roche Diagnostics Corporation, Indianapolis  46250.(**LightCycler 2.0 System, Catalog Number: 04391039001; Batch Number Range: 1415471-1415933; LightCycler 2.0 Instrument-Laptop; Catalog Number: 03603946001; Batch Number Range; 1415434-1415734; LightCycler 2.0 Instrument-Desktop; Catalog Number: 03531414201; Batch Number Range: 1415271-1415732",
      "code_info": "Lots 34979900, exp. 2/28/08; 35290100, exp. 2/28/08; 35293300 and 35296200 plus any capillaries received at the time of installation of the LightCycler instruments or systems**. (**LightCycler 2.0 System, Catalog Number: 04391039001; Batch Number Range: 1415471-1415933; LightCycler 2.0 Instrument-Laptop; Catalog Number: 03603946001; Batch Number Range; 1415434-1415734; LightCycler 2.0 Instrument-Desktop; Catalog Number: 03531414201; Batch Number Range: 1415271-1415732)",
      "firm_fei_number": "1823260",
      "recalling_firm": "Roche Diagnostics Corp.",
      "address_1": "9115 Hague Rd",
      "city": "Indianapolis",
      "state": "IN",
      "postal_code": "46250-0416",
      "additional_info_contact": "800-526-1247",
      "reason_for_recall": "False Negative Results: Air bubbles in the lens or the area surrounding the lens of the LightCycler 100 uL capillaries may cause false negative results. The affected capillaries showed up to a 40% reduction in signal",
      "root_cause_description": "Process design",
      "action": "Consignees were notified by Urgent Medical Device Recall letter dated 8/30/07, to discontinue use of the 100uL capillaries, plus all of those received at installation, and to disposed of them per local guidelines.",
      "product_quantity": "119 boxes of 96 capillaries each",
      "distribution_pattern": "Nationwide",
      "openfda": {
        "k_number": [
          "K903357",
          "K052794",
          "K833154",
          "K864236",
          "K781442",
          "K971491",
          "K802392",
          "K965103",
          "K040332",
          "K802398",
          "K863245",
          "K840200",
          "K830095",
          "K870777",
          "K973177",
          "K013654",
          "K820541",
          "K864834",
          "K851172",
          "K912055",
          "K850999",
          "K844586",
          "K771513",
          "K820415",
          "K852385",
          "K925093",
          "K964506",
          "K871486",
          "K833153",
          "K872120",
          "K833998",
          "K883020",
          "K790335",
          "K883350",
          "K964409",
          "K993634",
          "K771939",
          "K803004",
          "K790197",
          "K821583",
          "K942676",
          "K831227",
          "K893768",
          "K033734",
          "K961209",
          "K771821",
          "K781606",
          "K973628",
          "K833804",
          "K012966",
          "K802264",
          "K883298",
          "K851933",
          "K980056",
          "K851542",
          "K943978",
          "K820748"
        ],
        "registration_number": [
          "",
          "3008494306",
          "3024753119",
          "3003593973",
          "3008382976",
          "3031697086",
          "3010194621",
          "3005342322",
          "3006198300",
          "3025430789",
          "3004141078",
          "9610126",
          "3050015",
          "3023197868",
          "3010461097",
          "3004438098",
          "3008576040",
          "3003402518",
          "3009984016",
          "3003521949",
          "3009473156",
          "3004434309",
          "2432235",
          "3003559191",
          "2244900",
          "8043379",
          "2517506",
          "9610240",
          "3004493545",
          "3003795116",
          "2182595",
          "2050012"
        ],
        "fei_number": [
          "",
          "3008494306",
          "3024753119",
          "3003593973",
          "3008382976",
          "3031697086",
          "3010194621",
          "3005342322",
          "3002806559",
          "3006198300",
          "3025430789",
          "3004141078",
          "3050015",
          "3023197868",
          "3010461097",
          "3004438098",
          "3008576040",
          "3002808212",
          "3003402518",
          "3009984016",
          "3003521949",
          "3009473156",
          "3004434309",
          "2432235",
          "3003559191",
          "2244900",
          "3003413192",
          "2517506",
          "3004493545",
          "3003795116",
          "2182595",
          "2050012"
        ],
        "device_name": "Analyzer, Chemistry, Micro, For Clinical Use",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.2170",
        "device_class": "1"
      }
    }
  ]
}