{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "192365",
      "product_res_number": "Z-0945-2022",
      "event_date_initiated": "2022-01-09",
      "event_date_created": "2022-04-15",
      "recall_status": "Open, Classified",
      "res_event_number": "89755",
      "product_code": "QKP",
      "product_description": "Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked",
      "code_info": "Lots: COV1080201, COV1105014",
      "firm_fei_number": "3002829675",
      "recalling_firm": "Acon Biotech (Hangzhou) Co., Ltd.",
      "address_1": "398 Tianmushan Road",
      "city": "Hangzhou",
      "country": "China",
      "additional_info_contact": "011 86 858 200",
      "reason_for_recall": "Non-EUA authorized, CE marked, SARS-CoV-2 antigen rapid test kits are being recalled from the U.S. market because use may lead to inaccurate test results, including false negative or false positive test results.",
      "root_cause_description": "No Marketing Application",
      "action": "On 04/04/22, recall notices were sent to distributor customers who were asked to do the following:\n\nIf you may have further distributed this product, please identify your customers and notify them at once of this product correction. Your notification to your customers may be enhanced by including a copy of this correction notification letter.  This correction should be carried out to the consumer/user level in U.S.  Complete and return the response form to the recalling firm.\n\nCustomers with additional questions were encouraged to contact Denice Dong, Denice.Dong@aconlab.com.cn\n\nAdditional instructions in a press release were provided to address affected non-EUA devices, of unknown quantity, that may have entered the U.S. market. It is recommended to stop use and dispose of affected devices in the U.S. market: https://www.aconlabs.com/news/",
      "product_quantity": "303,760",
      "distribution_pattern": "US: MD, PA\n\nInternational Distribution to countries of: Hungary and China.",
      "openfda": {
        "registration_number": [
          "3008517993",
          "3004146366",
          "3004142665",
          "3020964039",
          "3002642396",
          "3043128348",
          "2250051",
          "3026478116",
          "3008054239",
          "3028107593",
          "3014862351",
          "2025099",
          "3027500452",
          "1000115322",
          "2432235",
          "3018786392",
          "3016761091",
          "3026565854",
          "2029372",
          "3016820006",
          "3018187017",
          "1319681",
          "3017662853",
          "3017887566",
          "3008573045",
          "3007111389",
          "3014022295",
          "3028746593",
          "2246703",
          "3016610313",
          "3014660585",
          "2431980",
          "3012133212",
          "3021090658",
          "3039321686",
          "3022474803",
          "3026478115",
          "3002821211",
          "2032682",
          "3009238284",
          "3004181896",
          "2024674",
          "3000308930",
          "3033507883",
          "3012963943",
          "3013160357",
          "9610240",
          "3008825965",
          "3017894300",
          "2030538",
          "1221359",
          "3011522054",
          "1122236",
          "3005360469",
          "3024756665",
          "3015883679",
          "3017171515",
          "3027518847",
          "3026664926",
          "9610126",
          "3003297763",
          "3011561946",
          "3032562",
          "3025041446",
          "3003896222",
          "3023372670",
          "1219913",
          "3016850770",
          "2020808",
          "3023947183",
          "3021082896",
          "3020305857",
          "3009014878",
          "3009963993",
          "3033751096",
          "3012516456",
          "3008925277",
          "3016837106",
          "3014654360",
          "3005984081",
          "3010934853",
          "3008959428",
          "3002792284",
          "1313700",
          "3039322300"
        ],
        "fei_number": [
          "3008517993",
          "3004146366",
          "3004142665",
          "3020964039",
          "3002642396",
          "3043128348",
          "2250051",
          "3026478116",
          "3008054239",
          "3028107593",
          "3014862351",
          "3027500452",
          "1000306617",
          "1000115322",
          "2432235",
          "3018786392",
          "3016761091",
          "3026565854",
          "3002606748",
          "3016820006",
          "3018187017",
          "3017662853",
          "3017887566",
          "3008573045",
          "1000520007",
          "3007111389",
          "3014022295",
          "3028746593",
          "2246703",
          "3016610313",
          "3004069780",
          "3014660585",
          "2431980",
          "3012133212",
          "3021090658",
          "3039321686",
          "3022474803",
          "3026478115",
          "3002821211",
          "3009238284",
          "3004181896",
          "2024674",
          "3002808212",
          "3000308930",
          "3033507883",
          "3012963943",
          "3013160357",
          "3008825965",
          "3002806559",
          "3017894300",
          "1221359",
          "3011522054",
          "1122236",
          "3010687142",
          "3024756665",
          "3015883679",
          "3017171515",
          "3027518847",
          "3003952975",
          "3026664926",
          "3003297763",
          "3011561946",
          "3005670738",
          "1000136573",
          "3025041446",
          "3023372670",
          "1219913",
          "3016850770",
          "2020808",
          "3023947183",
          "3021082896",
          "3020305857",
          "3009014878",
          "3009963993",
          "3007981058",
          "3033751096",
          "3012516456",
          "3016837106",
          "3014654360",
          "3005984081",
          "3010934853",
          "3008959428",
          "3002792284",
          "1313700",
          "3039322300"
        ],
        "device_name": "Coronavirus Antigen Detection Test System.",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "N"
      }
    }
  ]
}