{
  "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": "2026-08-12",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "status": "Ongoing",
      "city": "Austin",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "99360",
      "recalling_firm": "Nuclein LLC",
      "address_1": "8305 Cross Park Dr",
      "address_2": "",
      "postal_code": "78754-5154",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution in the state of Texas.",
      "recall_number": "Z-2861-2026",
      "product_description": "Brand Name: DASH Rapid PCR Instrument  Product Name: DASH Rapid PCR Instrument  Model/Catalog Number: SG-0002  Software Version: 6.0.2  Product 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.  Component: No.",
      "product_quantity": "2",
      "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).",
      "recall_initiation_date": "20250625",
      "center_classification_date": "20260803",
      "report_date": "20260812",
      "code_info": "Lot Code: SN: C01250010; UDI: (01)00850063063005(11)250218(21)C01250010; SW: 6.0.2 SN: C02250006; UDI:(01)00850063063005(11)250225(21)C02250006; SW: 6.0.2",
      "more_code_info": ""
    }
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}