{
  "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,
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  "results": [
    {
      "cfres_id": "71821",
      "product_res_number": "Z-0011-2009",
      "event_date_initiated": "2008-06-11",
      "event_date_posted": "2008-10-09",
      "recall_status": "Terminated",
      "event_date_terminated": "2009-09-22",
      "res_event_number": "48638",
      "product_code": "CIX",
      "k_numbers": [
        "K033009"
      ],
      "product_description": "Roche Diagnostics ALBT2, Tina-quant Albumin Gen. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 04469658190.\n\nAn in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of albumin concentration in serum and plasma.",
      "code_info": "Lot 60087801.",
      "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": "Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.",
      "root_cause_description": "Labeling Change Control",
      "action": "Consignees were notified via an Urgent Medical Device correction letter dated 6/11/08 informing users of the problem and providing them with work-around instructions.  The instructions suggests 1) inserting the cassette rack slowly; 2) using mainly reagent slots A, B, or C; 3) tilting the rack slightly clockwise so the barcode scanner does not read the barcode at an exact 90 degree angle; and 4) confirming the rack is properly seated on the track and displayed on the Cassette Status screen.  If the cassette barcode does not register after following the Work-Around instructions, then customers are required to contact Diagnostics Technical Support.",
      "product_quantity": "124",
      "distribution_pattern": "Nationwide Distribution",
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        "device_name": "Bromcresol Green Dye-Binding, Albumin",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1035",
        "device_class": "2",
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