{
  "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",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "197600",
      "product_res_number": "Z-1021-2023",
      "event_date_initiated": "2022-09-28",
      "event_date_posted": "2023-01-26",
      "recall_status": "Open, Classified",
      "res_event_number": "91384",
      "product_code": "LGC",
      "k_numbers": [
        "K983886"
      ],
      "product_description": "biokitHSV-2 Rapid Test, REF: 300028001",
      "code_info": "UDI-DI/Lots - Expiration Dates: 08426951056439/\nB34243 - 2022-09-30,\nB34309 - 2022-11-30,\nB34463 - 2022-11-30,\nB34465 - 2023-02-28,\nB35052 - 2023-05-31,\nB35188 - 2023-07-31,\nB35398 - 2023-10-31",
      "firm_fei_number": "3002806557",
      "recalling_firm": "Biokit, S.A.",
      "address_1": "Avinguda De Can Montcau 7 7 avinguda de can montcau",
      "city": "Llica D'Amunt",
      "state": "Barcelona",
      "country": "Spain",
      "reason_for_recall": "HSV-2 rapid test may report false positive results.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On 9/28/22, Werfen Field Action notices were emailed to customers who were asked to 1) Stop using and discard affected kits, 2) Complete and return the tracking form provided with the notice to oem-complaints@werfen.com, 3) Forward the notice to all affected facilities.\n\nOn 2/10/23, Werfen Field Action notices were emailed to additional customers informing them of an additional affected lot.\n\nOn 3/13/23, Werfen Field Action notices were emailed to an additional customer informing them of an additional affected lot.\n\nOn 4/11/23, Werfen Field Action notices were emailed to an additional customer informing them of an additional affected lot.",
      "product_quantity": "2,393",
      "distribution_pattern": "US Nationwide distribution in the states of NY, CA, IN, NC, VA.",
      "openfda": {
        "k_number": [
          "K963282",
          "K910955",
          "K843077",
          "K884680",
          "K925208",
          "K010878",
          "K910954",
          "K822883",
          "K981306",
          "K834449",
          "K900713",
          "K922584",
          "K984346",
          "K903070",
          "K963645",
          "K910499",
          "K922333",
          "K915551",
          "K871877",
          "K992166",
          "K910953",
          "K000238",
          "K983656",
          "K843622",
          "K983541",
          "K002262",
          "K922759",
          "K950670",
          "K033059",
          "K922334",
          "K884246",
          "K953839",
          "K922583",
          "K903926",
          "K983886",
          "K922758",
          "K802526",
          "K910952"
        ],
        "registration_number": [
          "1318354",
          "1641328",
          "3006198300",
          "3032705",
          "3005333358",
          "9617136",
          "3008344661",
          "2242436",
          "2090110",
          "9610746",
          "1827821",
          "2029372",
          "2023365",
          "2432235",
          "1036362",
          "3007208259",
          "3002806944",
          "3022178699"
        ],
        "fei_number": [
          "1318354",
          "1641328",
          "3006198300",
          "3005333358",
          "3002346973",
          "3008344661",
          "2242436",
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          "2432235",
          "1036362",
          "3007208259",
          "3002806557",
          "3002806944",
          "3022178699"
        ],
        "device_name": "Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3305",
        "device_class": "2"
      }
    }
  ]
}