{
  "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": "35294",
      "product_res_number": "Z-0325-05",
      "event_date_initiated": "2003-09-11",
      "event_date_posted": "2004-12-17",
      "recall_status": "Terminated",
      "event_date_terminated": "2009-10-05",
      "res_event_number": "30165",
      "product_code": "LIP",
      "k_numbers": [
        "K001552"
      ],
      "product_description": "The Is-Syphilis TREP-CHEK (TM) Test Kit is a confirmatory in vitro enzyme immunoassay for the qualitative detection of Treponema pallidum IgG antibodies in human serum or plasma. The reagents can be used either manually or in conjunction with the MAGO Plus or APTUS Automated EIA Processors. The FDA has not cleared this product for use in screening blood or plasma donors.\n\nThe kit is labeled with an expiration date of Mar 04 and requires storage at 2-8 degree Centigrade.The non conforming kit component is the Conjugate that consists of a glass bottle with red cap containing 30 ml goat anti-human IgG labeled with horseradish peroxidase.",
      "code_info": "The kit lot number is 42003. The conjugate lot number is 42023.",
      "firm_fei_number": "1044713",
      "recalling_firm": "Diamedix Corporation",
      "address_1": "2140 N Miami Ave",
      "city": "Miami",
      "state": "FL",
      "postal_code": "33127-4916",
      "reason_for_recall": "Several customers complained that either the negative control index value exceeded the upper control limit or there was very low activity of the cut off calibrator causing patient sample test runs to be called invalid.",
      "root_cause_description": "Other",
      "action": "Recall letter dated 10/8/03 was sent, via FEDEX, with replacement conjugate bottles to those accounts reporting remaining stock.The letter requested that the original conjugate bottle, lot number 42023 be discarded and replaced with new conjugate lot #71323z. The letter also included a new inner box label that had the lot number information for the new conjugate bottle.",
      "product_quantity": "490 kits",
      "distribution_pattern": "Distributed to 54 laboratory accounts throughout the US.",
      "openfda": {
        "k_number": [
          "K871548",
          "K904524",
          "K961317",
          "K883939",
          "K091361",
          "K241427",
          "K170413",
          "K050590",
          "K881425",
          "K153145",
          "K093837",
          "K001552",
          "K102400",
          "K063866",
          "K932453",
          "K153730",
          "K061247",
          "K895964",
          "K992552",
          "K112343",
          "K910487",
          "K211302",
          "K120439",
          "K160910",
          "K820934",
          "K241534",
          "K102283",
          "K895965",
          "K850329",
          "K883938",
          "K014233",
          "K900654",
          "K053570",
          "K001525",
          "K960493"
        ],
        "registration_number": [
          "9610240",
          "3026565854",
          "2122870",
          "2245285",
          "2029372",
          "2182595",
          "2032364",
          "2431980",
          "3002809144",
          "3009178048",
          "2432235",
          "1641328",
          "3005360469",
          "3032705",
          "1318354",
          "9610126",
          "3022178699",
          "3000254998",
          "3011989923",
          "1219913",
          "1319681",
          "3002800697",
          "3005333358",
          "8023060",
          "3002806944",
          "2915274",
          "2242436",
          "3002895169"
        ],
        "fei_number": [
          "3026565854",
          "2122870",
          "2245285",
          "2182595",
          "2431980",
          "3002809144",
          "3009178048",
          "3003323921",
          "2432235",
          "1641328",
          "3003992026",
          "3002808212",
          "1318354",
          "3022178699",
          "3000254998",
          "3011989923",
          "1219913",
          "2915274",
          "3002800697",
          "3005333358",
          "3005670738",
          "1000136573",
          "3002806944",
          "3002701146",
          "2242436",
          "3002806559",
          "3002895169",
          "1000306617"
        ],
        "device_name": "Enzyme Linked Immunoabsorption Assay, Treponema Pallidum",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3830",
        "device_class": "2"
      }
    }
  ]
}