{
  "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": "89064",
      "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": "Letter",
      "distribution_pattern": "Domestic distribution to AZ, CA, FL, HI, IN, KY, MD, MO, NC, NJ, NY, OH, OK, PA, TX, VA. Foreign distribution to Ghana, Dominican Republic, and Singapore.",
      "recall_number": "Z-0452-2022",
      "product_description": "Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824  Subcomponent of: SARS-CoV-2 Go-Strips, 3000555; SARS-CoV-2 Go-Plates, 3000562; SARS-Cov-2 Bulk Vials, 3000564",
      "product_quantity": "11,607",
      "reason_for_recall": "The current IFU specifies a shelf-life of one week after resuspension of the RPC Buffer when stored at room temperature. Ongoing stability studies have indicated the need to shorten the life of the RPC Buffer once resuspended from the current instruction of one week to two days when stored at room temperature (15degC-30degC).",
      "recall_initiation_date": "20211020",
      "center_classification_date": "20220104",
      "termination_date": "20240305",
      "report_date": "20220112",
      "code_info": "All lots. Last lot of Kit distributed with the old IFU is 20210914."
    }
  ]
}