{
  "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": "2026-09-17",
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    {
      "cfres_id": "192161",
      "product_res_number": "Z-0836-2022",
      "event_date_initiated": "2022-02-15",
      "event_date_created": "2022-03-30",
      "recall_status": "Open, Classified",
      "res_event_number": "89666",
      "product_code": "OOI",
      "k_numbers": [
        "K170558"
      ],
      "product_description": "Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. \nMeridian branded Revogene: Catalog Number 610210\nGenePOC branded Revogene: Catalog Number 130840",
      "code_info": "UDI: 00840733102318\nAll units in the field, all serial numbers.",
      "firm_fei_number": "1524213",
      "recalling_firm": "Meridian Bioscience Inc",
      "address_1": "3471 River Hills Dr",
      "city": "Cincinnati",
      "state": "OH",
      "postal_code": "45244-3023",
      "additional_info_contact": "Meridian Bioscience Technical Services (North America)\n800-343-3858",
      "reason_for_recall": "The photomultiplier tube, may have compromised functionality in some instruments. As a result, the user is likely to observe an increase in false-positive or indeterminate results.",
      "root_cause_description": "Component design/selection",
      "action": "A Letter dated 02/15/2022 sent via FedEx notified users of the risk of false-positives and provided instructions on how to recognize a compromised photomultiplier tube via error codes and based on various combinations of positive and indeterminate results.  If a positive result with the negative control is obtained or false positive suspected, users are to contact Technical Service and cease using the instrument. The company is developing software solution aimed at identifying photomultiplier tubes that are at risk for failure and is seeking a hardware fix to this issue.",
      "product_quantity": "452 units (398 US, 54 OUS)",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OR, PA, PR, RI, SD, TN, TX, UT, VA, VT, WI, WV and the countries of Australia, Chile, Italy, Switzerland.",
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        "device_name": "Real Time Nucleic Acid Amplification System",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.2570",
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