{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "42506",
      "product_res_number": "Z-0416-06",
      "event_date_initiated": "2005-10-28",
      "event_date_posted": "2006-01-24",
      "recall_status": "Terminated",
      "event_date_terminated": "2006-10-05",
      "res_event_number": "33825",
      "product_code": "MAO",
      "product_description": "Vysis LSI p16 (9p21)/CEP 9 (9p11-q11) Dual Color Probe Set; a locus specific identifier DNA probe consisting of a mixture of the LSI p16 probe labeled with a SpectrumOrange and the CEP 9 probe labeled with a SpectrumGreen fluorophore, accompanied with LSI/WCP Hybridization Buffer; 20 evaluations; Vysis Inc., Downers Grove, IL 60515; order number 32-190078",
      "code_info": "order number 32-190078, lots 42919, 45942, 53417, 57026, 59938, 60858",
      "firm_fei_number": "3005248192",
      "recalling_firm": "Abbott Molecular",
      "address_1": "1300 E Touhy Ave",
      "city": "Des Plaines",
      "state": "IL",
      "postal_code": "60018",
      "additional_info_contact": "Mr. Donald B. Braakman\n224-361-7246",
      "reason_for_recall": "The DNA-Probe has a target size of ~300 Kb region instead of the labeled ~190 Kb region.",
      "root_cause_description": "Other",
      "action": "Abbott Molecular sent letters dated October 2005 to their direct laboratory accounts on 10/28/05 via first class certified mail.  The accounts were informed of the discrepancy between the actual size and region of coverage produced by the affected lots and that described in the product literature.  The accounts were instructed to assess the impact of this discrepancy on the use of the product in their laboratory and to retain a copy of the letter with any of the affected product remaining in their inventory.",
      "product_quantity": "749 kits",
      "distribution_pattern": "Nationwide, Germany, Japan, Canada, Korea, India, Malaysia, Australia, Hong Kong, Chile & Singapore",
      "openfda": {
        "pma_number": [
          "P880045"
        ],
        "registration_number": [
          "2028492",
          "3005967741"
        ],
        "fei_number": [
          "3005967741",
          "1000125183"
        ],
        "device_name": "Dna-Probe, Human Chromosome",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "U"
      }
    }
  ]
}