{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Cypress",
      "address_1": "11331 Valley View St",
      "reason_for_recall": "Focus Diagnostics is providing an urgent safety notice for a correction to the labeling for Simplexa\" Flu A/B & RSV Direct (MOL2650). Focus Diagnostics received some customer complaints of Simplexa Flu A/B & RSV Direct assays with sporadic false signals, which may result in a higher false results rate due to a potential software spectral matrix and Direct Amplification Disc storage.",
      "address_2": "",
      "product_quantity": "614 kits",
      "code_info": "Model Number: MOL2650.  All Lot Numbers.  The expiration date of the 614 kits of MOL2650 that are impacted by this Correction ranges from 10/31/2014 to 5/31/2015.",
      "center_classification_date": "20140701",
      "distribution_pattern": "Nationwide Distribution",
      "state": "CA",
      "product_description": "Simplexa\" Flu A/B & RSV Direct, Model Number: MOL2650.  \t\t\t  510(k) K120413 \u0013 Simplexa\" Flu A/B & RSV Direct.    The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C.",
      "report_date": "20140709",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Focus Diagnostics Inc",
      "recall_number": "Z-1958-2014",
      "initial_firm_notification": "E-Mail",
      "product_type": "Devices",
      "event_id": "68347",
      "termination_date": "20141231",
      "more_code_info": "",
      "recall_initiation_date": "20140515",
      "postal_code": "90630-5366",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}