{
  "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": "131490",
      "product_res_number": "Z-0849-2015",
      "event_date_initiated": "2014-11-13",
      "event_date_posted": "2014-12-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-03-18",
      "res_event_number": "69766",
      "product_code": "PFS",
      "k_numbers": [
        "K132750"
      ],
      "product_description": "Illumina MiSeqDx Universal Kit 1.0, PN 15039608\n\nThe Illumina MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted sequencing of the resulting sample libraries. User-supplied analyte specific reagents are required for the preparation of libraries targeting specific genomic regions of interest. The MiSeqDx Universal Kit 1.0 is intended for use with the MiSeqDx instrument.",
      "code_info": "Serial No. M70130, M70189, M70108, M70165, M70166, M70175, M70172, M70103.",
      "firm_fei_number": "3003218906",
      "recalling_firm": "Illumina Inc",
      "address_1": "5200 Illumina Way",
      "city": "San Diego",
      "state": "CA",
      "postal_code": "92121",
      "additional_info_contact": "858-736-3861",
      "reason_for_recall": "It was discovered a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Universal Kit 1.0 on the MiSeqDx instrument.  The software cannot report insertions or deletions at specific genomic locations with\nrespect to the primer.",
      "root_cause_description": "Software design",
      "action": "A customer letter dated November 13, 2014, was sent to all customers who is using the MiSeqDx Universal Kit 1.0 on the MiSeqDx instrument. The letter informs the customers that Illumina has recently confirmed a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Universal Kit 1.0 on the MiSeqDx instrument. The software cannot report insertions or deletions at specific genomic locations with respect to the primer. The customer notification outlines the potential issues, the results of investigation, actions required, and next steps.  Customers are instructed to return the attached Verification form to confirm their receipt of the letter and document the results of any patient impact from the limitation.\n\nCustomers with technical questions or concerns, are instructed to contact their local support team or Illumina Technical Support at techsupport@illumina.com. \n\nCustomers with questions regarding the field action, are instructed to contact Illumina Regulatory Affairs at RA@illumina.com. For further questions, please call (858) 736-3861.",
      "product_quantity": "13 units",
      "distribution_pattern": "US Distribution to the states of  AZ, GA, CA, OH, and VA., and one Internationally to France.",
      "openfda": {
        "k_number": [
          "K132750"
        ],
        "registration_number": [
          "3003218906"
        ],
        "fei_number": [
          "3003218906"
        ],
        "device_name": "System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5900",
        "device_class": "2"
      }
    }
  ]
}