{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "172621",
      "product_res_number": "Z-1767-2019",
      "event_date_initiated": "2019-02-22",
      "event_date_created": "2019-06-10",
      "recall_status": "Open, Classified",
      "res_event_number": "82745",
      "product_code": "PCH",
      "k_numbers": [
        "K140377"
      ],
      "product_description": "xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic acids in human stool specimens or human stool   (GPP) Kit, IVD, REF  I032C0316.",
      "code_info": "Lot numbers IK032C-00061, exp. 11/30/2018; IK032C-00063, exp. 11/30/2018; IK032C-00064, exp. 12/31/2018; IK032C-00066, exp. 12/31/2018; IK032C-00067, exp. 11/30/2018; IK032C-00068, exp. 4/30/2019; IK032C-00069, exp. 7/31/2019; and IK032C-00071, exp. 12/31/2018; UDI 00840487100493.",
      "firm_fei_number": "3002777243",
      "recalling_firm": "Luminex Molecular Diagnostics",
      "address_1": "439 University Ave Suite 900 439 University Ave",
      "address_2": "Suite 900",
      "city": "Toronto",
      "country": "Canada",
      "reason_for_recall": "Reports have been received of lower MS2 MFI values when using the panel.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "The recalling firm issued letters via email dated 2/22/2019.",
      "product_quantity": "965 kits",
      "distribution_pattern": "Distribution from the firm's Austin, Texas, location was made to AL, AR, AZ, CA, FL, GA, IL, IN, MO, NC, ND, NJ, NY, OK, TN, TX, VA, and WI.  There was military distribution but no government distribution.",
      "openfda": {
        "k_number": [
          "K191160",
          "K243813",
          "DEN130003",
          "K232672",
          "K140407",
          "K220193",
          "K183023",
          "K252329",
          "K140377",
          "K242367",
          "K160459",
          "K251993",
          "K250324",
          "K170308",
          "K253722",
          "K142501",
          "K254032",
          "K220062",
          "K152955",
          "K182703",
          "K142033",
          "K191161",
          "K251868",
          "K183030",
          "K220607",
          "K190585",
          "K180041",
          "K242877",
          "K143005",
          "K181427",
          "K121894",
          "K251721",
          "K143648",
          "K140647",
          "K123274",
          "K140083",
          "K243885",
          "K230404"
        ],
        "registration_number": [
          "3014553740",
          "3004530258",
          "3004013603",
          "3006028115",
          "1119779",
          "3002773840",
          "3011781554",
          "1650733",
          "3007420875",
          "2024800",
          "3005360469",
          "3010749841",
          "3009613136",
          "3007799234",
          "3016838963",
          "3002777243"
        ],
        "fei_number": [
          "3014553740",
          "3004530258",
          "3004013603",
          "3006028115",
          "1119779",
          "3002773840",
          "3011781554",
          "3007420875",
          "2024800",
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          "3009613136",
          "3007799234",
          "3002524000",
          "3016838963",
          "3005670738",
          "3002777243"
        ],
        "device_name": "Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3990",
        "device_class": "2"
      }
    }
  ]
}