{
  "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": [
    {
      "country": "United States",
      "city": "Philadelphia",
      "address_1": "1015 Chestnut St",
      "reason_for_recall": "Users cannot complete testing due to a sign-error in the software component that controls the filter movement and results in an instrument failure and assay failure before results are generated.",
      "address_2": "",
      "product_quantity": "147 systems",
      "code_info": "Device Reference/Catalog Number (Black) - 1000003, (white) - 1000018. Software version 6.4.3    EUA - Emergency Use Authorization",
      "center_classification_date": "20210131",
      "distribution_pattern": "Domestic: FL, TX, IN, KY, OH, NY, CA, PA, MD.   Foreign: Canada, Zimbabwe.",
      "state": "PA",
      "product_description": "Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens. The RT-PCR test runs on a Franklin Real-Time PCR Thermocycler Device (Reference/Catalog Number 1000003,1000018) with the Software Controller version 6.4.3. The cycler has a \"baseboard\" unit with firmware and associated software component that control motorized movements of the optical filter carriage used for PCR detection.",
      "report_date": "20210210",
      "classification": "Class III",
      "openfda": {},
      "recalling_firm": "Biomeme, Inc.",
      "recall_number": "Z-0940-2021",
      "initial_firm_notification": "E-Mail",
      "product_type": "Devices",
      "event_id": "87153",
      "termination_date": "20210611",
      "more_code_info": "",
      "recall_initiation_date": "20210105",
      "postal_code": "19107-4316",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}