{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "104832",
      "product_res_number": "Z-0399-2012",
      "event_date_initiated": "2011-10-25",
      "event_date_posted": "2012-01-11",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-02-02",
      "res_event_number": "60230",
      "product_code": "KRZ",
      "k_numbers": [
        "K070819"
      ],
      "product_description": "VARIANT II Link Hemoglobin A1c Program Reorder Pack, \n1600 tests, IVD, For the determination of Hemoglobin A1c in human whole blood.\nContents:\nElution Buffer A , 1 x 2500 mL\nElution Buffer B, 1 x 2100 mL\nWash/Diluent Solution, 1 x 2500 mL\nCartridge Set\nCD ROM - 1\nCalibrator/Diluent Set\nWhole Blood Primer, 6 x 1 mL\nSample vials, 2 x 100\nInstruction Manual\n\nBio-Rad Laboratories, Inc., 400 Alfred nobel Drive, Hercules, CA 94547-1803.\n\nIntended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HLCP).",
      "code_info": "Catalog number: 270-2716: Lot 70211322; 70211432, 70211440; exp 3/31/2012",
      "firm_fei_number": "2915274",
      "recalling_firm": "Bio-Rad Laboratories, Inc.",
      "address_1": "4000 Alfred Nobel Drive",
      "city": "Hercules",
      "state": "CA",
      "postal_code": "94547-1803",
      "additional_info_contact": "Jolene Bartilson\n510-741-6114",
      "reason_for_recall": "It was discovered that the Variant II Turbo Link Calibrator Values card contains incorrect values for IFCC units.  The numbers are missing a decimal point.",
      "root_cause_description": "Process control",
      "action": "Bio-Rad Laboratories, Inc. sent a Medical Device Correction Notification letter dated October 25, 2011, via Federal Express to all affected customers.  The letter identified the product, the problem, and the action to be taken by the customer.   The correction was initiated by the firm, customers were instructed to contact their regional Bio-Rad office for any questions.\nFor questions regarding this recall call 510-741-6114.",
      "product_quantity": "63",
      "distribution_pattern": "Nationwide Distribution including MI, SC, OH, IL, MN, MD, VA, NY and WI.",
      "openfda": {
        "k_number": [
          "K854166",
          "K840261",
          "K871283",
          "K792358",
          "K883851",
          "K842668",
          "K883703",
          "K831872",
          "K883850",
          "K882600",
          "K896921",
          "K831814",
          "K052101",
          "K962864",
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          "K822327",
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          "K041130",
          "K840010",
          "K951071",
          "K873832",
          "K822046",
          "K831306",
          "K902892",
          "K800852"
        ],
        "registration_number": [
          "2915274",
          "3007603826",
          "2432235",
          "3000148879",
          "1219029",
          "3003741796",
          "3005333358",
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          "2182501",
          "3014150341",
          "2050010",
          "1064608",
          "2221819",
          "1950302",
          "9610126",
          "2050012",
          "1064130",
          "3016438761"
        ],
        "fei_number": [
          "2915274",
          "3007603826",
          "2432235",
          "3000148879",
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          "3003741796",
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          "3005333358",
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          "2050010",
          "2221819",
          "1950302",
          "2050012",
          "3016438761",
          "3002684533",
          "3003071743"
        ],
        "device_name": "Calibrator For Hemoglobin And Hematocrit Measurement",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.8165",
        "device_class": "2"
      }
    }
  ]
}