{
  "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,
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  "results": [
    {
      "cfres_id": "221406",
      "product_res_number": "Z-2861-2026",
      "event_date_initiated": "2025-06-25",
      "event_date_posted": "2026-08-03",
      "recall_status": "Open, Classified",
      "res_event_number": "99360",
      "product_code": "NSU",
      "k_numbers": [
        "K241652"
      ],
      "product_description": "Brand Name: DASH Rapid PCR Instrument\nProduct Name: DASH Rapid PCR Instrument\nModel/Catalog Number: SG-0002\nSoftware Version: 6.0.2\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.\nComponent: No.",
      "code_info": "Lot Code: SN: C01250010; UDI: (01)00850063063005(11)250218(21)C01250010; SW: 6.0.2\nSN: C02250006; UDI:(01)00850063063005(11)250225(21)C02250006; SW: 6.0.2",
      "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 which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).",
      "root_cause_description": "Process control",
      "action": "On 06/25/2025, a \"MEDICAL DEVICE RECALL\" Letter was emailed to customers informing them that, Nuclein identified an incorrect software file on a small number of DASH instruments that creates a possibility for the affected instruments to make incorrect calls that indicate coinfection in the patient tested.\n\nOn 07/16/2026, the firm emailed an updated \"URGENT: MEDICAL DEVICE RECALL\" Letter.\n\n-Customer were informed regarding updates to the reason for the recall and potential health risks.\n-Customer were instructed to:\nAll affected DASH Instrument identified in Section 6 (below) have already been replaced.\nPlease complete the Acknowledgement and Receipt Form below and either email the completed form to customersupport@nuclein.com or mail to the address provided at the bottom of the Acknowledgement and Receipt Form.\n\nFor Questions - contact Nuclein at Phone: (888) 992-DASH on Monday through Friday, 8:30 AM to 5:30 PM, CST.\nEmail: customersupport@nuclein.com\nWebsite: https://www.Nuclein.com/contact-us/",
      "product_quantity": "2",
      "distribution_pattern": "US Nationwide distribution in the state of Texas.",
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        "device_name": "Instrumentation For Clinical Multiplex Test Systems",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.2570",
        "device_class": "2"
      }
    }
  ]
}