{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Philadelphia",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86757",
      "recalling_firm": "Biomeme, Inc.",
      "address_1": "1015 Chestnut St",
      "address_2": "N/A",
      "postal_code": "19107-4316",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution including in the states of CA, IN, NY, OH, PA, and the countries of Canada, Singapore, Zimbabwe, and Dominican Republic.",
      "recall_number": "Z-0513-2021",
      "product_description": "The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used nucleic acid amplification technology. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test contains primers and probes and internal controls used in RT-PCR for the in vitro qualitative detection of SARS-CoV-2 RNA in upper respiratory specimens. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test utilizes Biomeme\u0019s M1 Sample Prep Cartridge for RNA extraction, Biomeme\u0019s SARS-CoV-2 Go-Strips assay, and Biomeme\u0019s portable Franklin\" Real-Time qPCR Thermocycler. Franklin\u0019s companion mobile app, Biomeme Go, scans tests, runs PCR experiments online or offline, and is used to quickly interpret your test results while conveniently syncing data to the Biomeme Cloud. Biomeme: 1000013 (Android Smartphone w/ Biomeme Go Mobile App) and Biomeme: 1000012 (Rugged Android Smartphone w/ Biomeme Go Mobile App) are controller for Biomeme Franklin thermocycler.",
      "product_quantity": "105",
      "reason_for_recall": "The firm has become aware of nine reports by a single customer that the software made false positive calls. The investigation determined that the root cause is the higher than expected amber-to-red co-excitation in the assay.",
      "recall_initiation_date": "20201023",
      "center_classification_date": "20201201",
      "termination_date": "20210125",
      "report_date": "20201209",
      "code_info": "Revision  2020-03-24",
      "more_code_info": ""
    }
  ]
}