{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "221403",
      "product_res_number": "Z-3164-2026",
      "event_date_initiated": "2025-10-22",
      "event_date_posted": "2026-09-14",
      "recall_status": "Open, Classified",
      "res_event_number": "99356",
      "product_code": "NSU",
      "k_numbers": [
        "K241652"
      ],
      "product_description": "Brand Name: DASH Rapid PCR Instrument\r\nProduct Name: DASH Rapid PCR Instrument\r\nModel/Catalog Number: SG-0002\r\nSoftware Version: 6.0.2, 6.0.4, 6.0.5, 6.0.6\r\nProduct Description: The DASH Rapid PCR Instrument (DASH Instrument) is an automated, fluorescence-based, reverse-transcription polymerase chain reaction (RT-PCR) instrument that extracts specimens and performs nucleic acid amplified tests (NAAT) in DASH test cartridges for the qualitative detection of infectious diseases. The DASH Instrument is intended for use in conjunction with DASH Rapid PCR System tests to aid in the diagnosis of infectious diseases.\r\nComponent: No.",
      "code_info": "Instrument Serial Numbers / UDI codes:\nC01250001\t(01)00850063063005(11)250217(21)C01250001\nC01250003\t(01)00850063063005(11)250217(21)C01250003  \nC01250004\t(01)00850063063005(11)250214(21)C01250004\nC01250005\t(01)00850063063005(11)250214(21)C01250005\nC01250006\t(01)00850063063005(11)250218(21)C01250006\nC01250007\t(01)00850063063005(11)250218(21)C01250007\nC01250008\t(01)00850063063005(11)250218(21)C01250008\nC01250009\t(01)00850063063005(11)250218(21)C01250009\nC01250010\t(01)00850063063005(11)250218(21)C01250010    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\nC07250040\t(01)00850063063005(11)250730(21)C07250040\nC07250041\t(01)00850063063005(11)250729(21)C07250041\nC07250042\t(01)00850063063005(11)250729(21)C07250042  \nC07250043\t(01)00850063063005(11)250730(21)C07250043\nC07250044\t(01)00850063063005(11)250731(21)C07250044\nC07250045\t(01)00850063063005(11)250731(21)C07250045\nC07250047\t(01)00850063063005(11)250731(21)C07250047  \nC07250048\t(01)00850063063005(11)250801(21)C07250048  \nC07250050\t(01)00850063063005(11)250731(21)C07250050    \nC07250051\t(01)00850063063005(11)250801(21)C07250051  \nC07250052\t(01)00850063063005(11)250801(21)C07250052  \nC07250053\t(01)00850063063005(11)250804(21)C07250053  \nC07250055\t(01)00850063063005(11)250804(21)C07250055  \nC07250056\t(01)00850063063005(11)250805(21)C07250056\nC07250057\t(01)00850063063005(11)250804(21)C07250057  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      "firm_fei_number": "3014515702",
      "recalling_firm": "Nuclein LLC",
      "address_1": "8305 Cross Park Dr",
      "city": "Austin",
      "state": "TX",
      "postal_code": "78754-5154",
      "additional_info_contact": "Customer Support\n+1-888-9923274",
      "reason_for_recall": "Due to a software issue",
      "root_cause_description": "Process control",
      "action": "On 10/22/2025 a \"Customer Advisory Notification\" via email to customers informing them of a software update to deal with potential of aborted test runs due to Error Code 0x25000012 (Pressure wet filter error).\n\nCustomer were informed that an over-the-air software update will automatically be available when the DASH Instrument is connected to the internet.\n\nFor questions or assistance - Nuclein Customer Support at 1-888-992-DASH (3274) or customersupport@nuclein.com\n\nOn 07/30/2026, an updated \"URGENT: MEDICAL DEVICE CORRECTION\" Letter was email to customers.  The updated letter informed customer of the potential issues associated with the software issue that was not addressed in the initial letter sent on 10/22/2025.",
      "product_quantity": "182",
      "distribution_pattern": "US Nationwide distribution in the states of Alabama, Delaware, Florida, Georgia, Kansas, Massachusetts, , Maryland, Maine, Michigan, North Carolina, New York, Ohio, South Carolina, Tennessee, Texas, Virginia, Vermont.",
      "openfda": {
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        "device_name": "Instrumentation For Clinical Multiplex Test Systems",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.2570",
        "device_class": "2"
      }
    }
  ]
}