{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "184565",
      "product_res_number": "Z-0510-2021",
      "event_date_initiated": "2020-11-05",
      "event_date_created": "2020-12-01",
      "recall_status": "Terminated",
      "event_date_terminated": "2021-04-16",
      "res_event_number": "86798",
      "product_code": "QMN",
      "product_description": "ACCEL ELISA COVID-19 for the detection of total antibodies to SARS-CoV-2\nCatalog AE301U\n\nKit lots: PXCOV073020, PXCOV081220\nExpiration dates: January 18, 2021 and January 26, 2021",
      "code_info": "Kit lots: PXCOV073020, PXCOV081220 Expiration dates: January 18, 2021 and January 26, 2021",
      "firm_fei_number": "3017223053",
      "recalling_firm": "VEO DIAGNOSTICS, LLC",
      "address_1": "422 Wards Corner Rd",
      "city": "Loveland",
      "state": "OH",
      "postal_code": "45140-6964",
      "reason_for_recall": "Emergency Use Authorization (EUA) removed from list of COVID-19 antibody tests",
      "root_cause_description": "Device Design",
      "action": "Plexense issued NOTICE  IMPORTANT PRODUCT WITHDRAWAL dated 11/5/20, stating reason for withdrawal, health risk and action take:\nclinical decisions.\n\" If this test has been used to make clinical decisions, evaluate each patients clinical presentation and medical history, whether prior test results generated using this test may have been incorrect, and whether the patient should be retested using an FDA-authorized test.\n\" Complete the Customer Response Form that accompanies this letter and return it to VEO Diagnostics, Plexenses US distributor, to confirm that you have received and understand this Notification. VEOs return address is listed on the Customer Response Form.\n\" Remove from your stock any remaining ACCEL ELISA COVID-19 tests that you have in your possession and discard those kits. Indicate their destruction or disposal on the Customer Notification Form. You DO NOT need to return the kits to VEO Diagnostics or Plexense, Inc.\n\" If you were using ACCEL ELISA COVID-19 for research purposes, and you wish to continue with your research, please contact VEO Diagnostics at 513-965-3140 for assistance with obtaining replacement materials to continue your research.\nShould you have additional questions regarding this Notification, or if you need assistance, please contact VEO Diagnostics Product Support team at:\nTelephone : 513-965-3140\nFax : 513-961-2858",
      "product_quantity": "15 kits",
      "distribution_pattern": "US Nationwide distribution including in the states of IA, PA, WA.",
      "openfda": {
        "registration_number": [
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          "3016252795",
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          "2020808",
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        ],
        "fei_number": [
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          "3016252795",
          "3003516723",
          "1000306617",
          "3006948883",
          "3033751096",
          "3008573045",
          "3033507883",
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          "3009238284",
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          "3008054239",
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          "3007606081",
          "3002792284",
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          "3004635103",
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          "2020808",
          "3017550662",
          "3005174594",
          "3023947183",
          "3028107593",
          "3032171519"
        ],
        "device_name": "Covid-19 Multi-Analyte Antigen Device",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "N"
      }
    }
  ]
}