{
  "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": {
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  "results": [
    {
      "cfres_id": "32194",
      "product_res_number": "Z-0771-04",
      "event_date_initiated": "2003-09-29",
      "event_date_posted": "2004-07-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2005-06-08",
      "res_event_number": "28595",
      "product_code": "GKP",
      "product_description": "Coag-A-Mate MTX and MTX II Instrument Operator Manual",
      "code_info": "All Codes",
      "firm_fei_number": "1039284",
      "recalling_firm": "Biomerieux, Inc.",
      "address_1": "100 Rodolphe St",
      "city": "Durham",
      "state": "NC",
      "postal_code": "27712-9402",
      "additional_info_contact": "bioMerieux Local Customer Representative\n919-920-2968",
      "reason_for_recall": "Typographical error in the Operator Manual. In Chapter 11 of the MTX/MTX II Operator Manual, the numerical range for the Warning Flag is shown as 00-99. The correct numerical range is 0-99. The 'list of error and warning' chart shows a numerical range representing the codes 00-9. The correct numerical range for the first ten error/warning codes are 0-9.",
      "root_cause_description": "Other",
      "action": "Consignees were notified by letter on September 29, 2003.",
      "product_quantity": "unknown",
      "distribution_pattern": "Nationwide, Argentina, Australia, Austria, Belgium, Brazil, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Greece, HK, India, Italy, Ivory Coast, Japan, Korea, Mexico, Netherlands, N. Zealand, Norway, Poland, Portugal, Russia, Spain, Sweden, Switzerland, Turkey, UK.",
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        "device_name": "Instrument, Coagulation, Automated",
        "medical_specialty_description": "Hematology",
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