{
  "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": "2026-08-20",
    "results": {
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  "results": [
    {
      "cfres_id": "191872",
      "product_res_number": "Z-0719-2022",
      "event_date_initiated": "2022-01-31",
      "event_date_created": "2022-03-16",
      "recall_status": "Open, Classified",
      "res_event_number": "89527",
      "product_code": "QKP",
      "product_description": "STANDARD Q COVID-19 Ag Home Test\n\nSTANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.",
      "code_info": "REF No. Q-NCOV-03G\nCatalog No.: 09COV130\nLot Number: 59628J1T1 (Potentially 59628J1T1/2)",
      "firm_fei_number": "3012133212",
      "recalling_firm": "SD Biosensor, Inc.",
      "address_1": "1556 Beon-Gil, Yeongtong 1556 Beon-Gil Yeongtong C4th & 5th Floor Digital Empire Bldg 16 Deogyeong-Daero Suwon Korea the Republic of",
      "additional_info_contact": "Priscilla Chung\n714-202-5789",
      "reason_for_recall": "Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved, cleared or authorized for distribution within the U.S.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On 02/02/2022, SD Biosensor, Inc. a global in-vitro diagnostic company notified U.S Food and Drug Administration (US FDA) that the firm was voluntarily recalling its STANDARD Q COVID-19 Ag Home Test kits due to confirmed reports that the test kits were illegally imported into the U.S.  The Home Test kits are not approved or authorized by the US FDA for sale in the U.S.\n\nUS FDA was informed that the SD Biosensor, Inc. sent a \"Cease and Desist Letter Related to STANDARD Q COVID-19 Ag Test in the USA\" demanding that the distributor take immediate action to cease and desist from all further sale or activities related to the product for use in the USA.\n\nFor questions/assistance:\nU.S. Contact - Tel: +1-714-202-5789 or email info@lkconsultinggroup.com\nKorea Contact - Tel: 070-4498-0742",
      "product_quantity": "~400,000 kits",
      "distribution_pattern": "U.S. Nationwide Distribution",
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        "device_name": "Coronavirus Antigen Detection Test System.",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "N"
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    }
  ]
}