{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "196556",
      "product_res_number": "Z-0324-2023",
      "event_date_initiated": "2022-08-08",
      "event_date_posted": "2022-11-29",
      "recall_status": "Open, Classified",
      "res_event_number": "91032",
      "product_code": "QJR",
      "product_description": "CoViPoint COVID test kit (MultiPLEX/Direct)\nKit Item Numbers:\nBC-DK0200;\nBM-AD4K0200\nBM-ADK0200\nBM-CDK0200\nBM-CFDK0200\nBM-D4K0200\nBM-DK0200\nBM-DK0600\nBM-DK0800\nBM-DK1200\nBM-DK1400\nBM-DK1800",
      "code_info": "CoViPoint COVID test kit (MultiPLEX/Direct)\nKit Item Numbers / Lot Numbers:\nBC-DK0200 / 42821005\n\nBM-AD4K0200 / 110421005, 110121005, 62322004\n\nBM-ADK0200 / 110121003\n\nBM-CDK0200 / 110121004\n\nBM-CFDK0200 / 110121006\n\nBM-D4K0200 / 71221003, 72021004, 81021003, 92721002, 102521003, 112221002, 30122001\n\nBM-DK0200 / 51821001, 71221002, 72021003, 72721001, 80521001, 80921003, 81021002, 90721003, 90721004, 90921003, 90921003, 90921003, 102521002, 111521002, 22422002\n\nBM-DK0600 / 110521002, 10722003, 12122004\n\nBM-DK0800 / 12722006\n\nBM-DK1200 / 120221002, 50222002\n\nBM-DK1400 / 92421002, 101821005, 32222004\n\nBM-DK1800 / 92321001, 92421001, 101821004, 110521001, 112321001, 120221001, 10722002, 12122002, 12722005, 32222003, 50222001, 60622001, 62922001",
      "firm_fei_number": "3024479668",
      "recalling_firm": "GS Biomark LLC",
      "address_1": "1120 116th Ave NE, Suite 102 1120 116th Ave NE",
      "address_2": "Suite 102",
      "city": "Bellevue",
      "state": "WA",
      "postal_code": "98004",
      "additional_info_contact": "Stacie Nelson\n888-339-0600",
      "reason_for_recall": "Distribution of COVID Test Kits without FDA Approval, Clearance or Authorization.",
      "root_cause_description": "No Marketing Application",
      "action": "On 08/08/2022, GS Biomark emailed customer to notify them that their COVID test kits - CoViPoint COVID test kit (MultiPLEX/Direct) have expired and to destroy unused material \n that they still have on-hand.\n\nCustomer were not informed that the affected products did not have Emergency Use Authorization to distributed the product within the U.S.",
      "product_quantity": "639,200 kits",
      "distribution_pattern": "U.S.: TX, NY, GA, IN, MD, CA, PA, MD, DC, NJ, OR, WA\n\nO.U.S.: None",
      "openfda": {
        "device_name": "Reagents, 2019-Novel Coronavirus Nucleic Acid",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "N",
        "registration_number": [
          "2032682",
          "3010607747",
          "3024647994",
          "3008517993",
          "2031468",
          "3012758946",
          "3016619649",
          "1528450",
          "3009014878",
          "3009207631",
          "3008632402",
          "3010749841",
          "3009238284",
          "3005248192",
          "3004013603",
          "2024800",
          "3019837962",
          "3010770794",
          "2243471",
          "3014214006",
          "3013540184",
          "9610126",
          "3038610665",
          "3017358793",
          "3016994837",
          "1221359",
          "3012918440",
          "3009875001",
          "3025663244",
          "3003902721",
          "1063851",
          "3009613136",
          "3032562",
          "3003795116",
          "3004146366",
          "3003335080",
          "1524213",
          "2023365",
          "3016608638",
          "3009976420",
          "3003517954",
          "3007420875",
          "3024756665",
          "3011104381",
          "3017638293",
          "3004530258",
          "1119779",
          "3016838963",
          "3004141078",
          "3014553740",
          "3017485950",
          "3002792284",
          "3013160357",
          "9615778",
          "3013019728"
        ],
        "fei_number": [
          "3010607747",
          "3024647994",
          "3008517993",
          "3003952975",
          "3012758946",
          "3016619649",
          "3009014878",
          "3009207631",
          "3008632402",
          "3010749841",
          "3009238284",
          "3005248192",
          "3004013603",
          "2024800",
          "1000351505",
          "3019837962",
          "3010770794",
          "2243471",
          "3014214006",
          "3013540184",
          "3038610665",
          "1000122536",
          "3017358793",
          "3016994837",
          "1221359",
          "3012918440",
          "3009875001",
          "3025663244",
          "3003902721",
          "3002806559",
          "3009613136",
          "3004146366",
          "3003795116",
          "3003335080",
          "1524213",
          "2023365",
          "3002023342",
          "3016608638",
          "3009976420",
          "3003517954",
          "3007420875",
          "3024756665",
          "3011104381",
          "3017638293",
          "3004530258",
          "3002606748",
          "1119779",
          "3016838963",
          "3004141078",
          "3014553740",
          "3017485950",
          "3002792284",
          "3013160357",
          "1000442352",
          "3013019728"
        ]
      }
    }
  ]
}