{
  "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": "191366",
      "product_res_number": "Z-0568-2022",
      "event_date_initiated": "2022-01-10",
      "event_date_created": "2022-02-17",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-09-27",
      "res_event_number": "89374",
      "product_code": "QBD",
      "product_description": "RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the following catalog numbers of RNAstill MTM specimen collection kits:  MTM-SW03 with Oropharyngeal swab and MTMSW-05 with Nasopharyngeal swab, packaged 25 specimen collection kits per plastic sleeve.\n\nRNAstill Molecular Transport Medium (MTM) safely deactivates pathogens at the point of collection and stabilizes RNA and DNA, allowing safe transport of specimens at ambient temperature from the collection site to the laboratory with no need for dry ice and no need for special containment facilities.",
      "code_info": "Catalog #MTM-SW03:  Lot numbers MG18401, MG18409, HH04806, KM02643, MG27906, MG28502,MG30295, and MG33903.  Catalog #MTM-SW05:  Lot numbers MG18401, MG18408, MG27901, and KC28836.",
      "firm_fei_number": "3016814582",
      "recalling_firm": "BASE 10 GENETICS INC",
      "address_1": "70 E Lake St Ste 226 70 E Lake St",
      "address_2": "Ste 226",
      "city": "Chicago",
      "state": "IL",
      "postal_code": "60601-7650",
      "additional_info_contact": "Jaymie Wertz\n214-784-6244",
      "reason_for_recall": "The product does not have 510(k) clearance.",
      "root_cause_description": "No Marketing Application",
      "action": "The recalling firm issued letters dated 1/10/2022 to the main office locations of the end-user facilities explaining the reason for recall, hazard involved, and requesting they discontinue use per their instruction on 11/30/2021.  (The main office locations were only instructed to discontinue use at that time and the product was not under recall then.)  The letter requested return of the kits as soon as possible and the firm's Client Success team will contact the end-user facilities to provide detailed instructions to complete and return.  An Acknowledgement and Receipt Form was enclosed for completion and return via email to the firm.\n\nThe Client Success Team began sending follow-up emails to the end-user facilities on 1/11/2022 which provided the number of kits the firm should have and that they should be returned by 1/21/2022.  Attached was a return shipping label and a guide with additional details on how to return the kits.  The follow-up email also contained the reason for recall and hazard involved.\n\nThe home office for the end-user facilities sent out emails beginning 1/11/2022 to their end-user facilities containing the subject line \"COVID-19 UPDATE: Base10 Test Kit Recall Instructions.\"  The email contained an advisory which said facilities should not be discarding old Base10 test kits that were discontinued for use.  It also said that Base 10 will be performing a recall on all RBC Kits beginning today and the end user will receive formal notification from Base 10 as well.  Return instructions were sent with the email.",
      "product_quantity": "455,791 kits",
      "distribution_pattern": "US Nationwide distribution in the states of AL, CO, FL, GA, ID, IN, KY, MD, NC, NV, NY, OH, OR, TN, UT, VA, WA, and WV.",
      "openfda": {
        "device_name": "Microbial Nucleic Acid Storage And Stabilization Device",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.2950",
        "device_class": "2",
        "k_number": [
          "K212113",
          "K231013",
          "K242820",
          "K222771",
          "K221664",
          "K223497",
          "K220059",
          "K221547",
          "K212878",
          "K240797",
          "DEN170029",
          "K210440",
          "K221802",
          "K201849",
          "K211675",
          "K233324",
          "K202641"
        ],
        "registration_number": [
          "3003272500",
          "3013373509",
          "1216735",
          "3025663244",
          "3013740892",
          "3016764932",
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          "1616487",
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          "2436875",
          "3017101757",
          "3016741564",
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          "3016838963",
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          "3004530258",
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        ],
        "fei_number": [
          "3003272500",
          "3013373509",
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          "3025663244",
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          "3016764932",
          "1000521444",
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          "3017101757",
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          "3012758946",
          "3013046485",
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          "3016838963",
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        ]
      }
    }
  ]
}