{
  "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": "66439",
      "product_res_number": "Z-0575-2008",
      "event_date_initiated": "2007-11-13",
      "event_date_posted": "2008-04-22",
      "recall_status": "Terminated",
      "event_date_terminated": "2008-07-23",
      "res_event_number": "45892",
      "product_code": "NVI",
      "k_numbers": [
        "K043341"
      ],
      "product_description": "BioRad BioPlex 2200 Software, for BioPlex 2200 Instrument, an automated immunodiagnostic analyzer, Bio-Rad Laboratories, Inc., Hercules, CA 94547",
      "code_info": "All software version 2.0, used with Calibrator Lots 86280 and 86290.",
      "firm_fei_number": "2915274",
      "recalling_firm": "Bio-Rad Laboratories Inc",
      "address_1": "4000 Alfred Nobel Dr",
      "city": "Hercules",
      "state": "CA",
      "postal_code": "94547-1803",
      "additional_info_contact": "510-724-7000",
      "reason_for_recall": "Incorrect values:  An error was found in the BioPlex 2200 Software, Version 2.0 that results in assignment values being utilized for the BioPlex assay Calibrator Set that may be slightly different from those printed on the Value Assignment Data Sheet.  Some values may be identical between the lot assignment combinations with the ANA Screen with MDSS kit.",
      "root_cause_description": "Software design",
      "action": "Bio-Rad sent a Voluntary Field Correction notice dated November 1, 2007.  Consignees were notified by phone call on Nov. 13, 2007, followed up by facsimile (domestic). Sub-recall to be by e-mail message for consignees outside the US.   Distribution of the product ceased on Nov. 2, 2007.  Bio-Rad will provide Calibrator Set CDs with only one lot of calibrator assignment values until a new version of software is available.",
      "product_quantity": "85 units of calibrator lot 86280 and 16 units of calibrator lot 86290 were distributed.",
      "distribution_pattern": "Worldwide Distribution - USA, Canada, France, and Germany.",
      "openfda": {
        "device_name": "Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3100",
        "device_class": "2",
        "registration_number": [
          "2915274"
        ],
        "fei_number": [
          "2915274"
        ],
        "k_number": [
          "K043341"
        ]
      }
    }
  ]
}