{
  "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": "190410",
      "product_res_number": "Z-0452-2022",
      "event_date_initiated": "2021-10-20",
      "event_date_created": "2022-01-04",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-03-05",
      "res_event_number": "89064",
      "product_code": "QJR",
      "product_description": "Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824\n\nSubcomponent of: SARS-CoV-2 Go-Strips, 3000555; SARS-CoV-2 Go-Plates, 3000562; SARS-Cov-2 Bulk Vials, 3000564",
      "code_info": "All lots. Last lot of Kit distributed with the old IFU is 20210914.",
      "firm_fei_number": "3014117298",
      "recalling_firm": "Biomeme, Inc.",
      "address_1": "1015 Chestnut St",
      "city": "Philadelphia",
      "state": "PA",
      "postal_code": "19107-4316",
      "additional_info_contact": "Max Perelman\n267-930-7707",
      "reason_for_recall": "The current IFU specifies a shelf-life of one week after resuspension of the RPC Buffer when\nstored at room temperature. Ongoing stability studies have indicated the need to shorten the life\nof the RPC Buffer once resuspended from the current instruction of one week to two days\nwhen stored at room temperature (15degC-30degC).",
      "root_cause_description": "Incorrect or no expiration date",
      "action": "On October 20, 2021, the firm sent an informal notice to customers titled \"Product Update: Storing your RNA Process Control (RPC)\". On November 4, 2021, the firm followed up with a formal notice titled \"Medical Device Correction\". The letter notified customers of the need to shorten the life of the RPC Buffer once resuspended from one week to TWO DAYS while stored at room temperature (15 degrees Celsius - 30 degrees Celsius). \n\nActions to be taken by the Customer:\nEffective immediately, users of resuspended RPC Buffer should discard after two days when\nstored at room temperature.\nFor longer-term storage, the RPC Buffer can be frozen once, at a temperature of -20C, for up\nto 3 months, and should not be frozen and thawed more than once.\nThe expiration date of unopened RPC Kits will remain the same.\n\nCustomers were also instructed to confirm receipt of the notification through a link provided by the firm.\n\nCustomers should discard any other documents they may have on-hand that specifies the longer shelf-life stated in the IFU. When available, Biomeme will deliver updated versions of the IFU to all users by email.",
      "product_quantity": "11,607",
      "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.",
      "openfda": {
        "device_name": "Reagents, 2019-Novel Coronavirus Nucleic Acid",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "N",
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