{
  "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": {
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  "results": [
    {
      "cfres_id": "130964",
      "product_res_number": "Z-0465-2015",
      "event_date_initiated": "2014-10-23",
      "event_date_posted": "2014-12-16",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-01-22",
      "res_event_number": "69566",
      "product_code": "LIB",
      "product_description": "Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, Lot 1301912.  The product is a latex agglutination test for the identification of predominant Legionella species grown on plate media from patients with suspected Legionellosis or from environmental sources. The test allows a separate identification of Legionella pneumophila serogroup 15 and serogroups 1-14 and detection of other pathogenic non L. pneumophila, Legionella strains.",
      "code_info": "DR0802M box lot 1301909, Exp. 30Sep2014",
      "firm_fei_number": "1924669",
      "recalling_firm": "Remel Inc",
      "address_1": "12076 Santa Fe Trail Dr",
      "city": "Lenexa",
      "state": "KS",
      "postal_code": "66215-3519",
      "additional_info_contact": "Earleen C. Parks\n913-895-4185",
      "reason_for_recall": "A reagent within the test may return false negative results.",
      "root_cause_description": "Other",
      "action": "ThermoFisher sent a Medical Device Recall letter dated October 23, 2014.  The letter identified the product, the problem, and the action to be taken by the customer.  Customers were instructed to notify any personnel who need to be aware of the potential for false negative results for the affected product.  Customers should review their inventory for the affected products and discard them.  Return the attached Medical Device Recall Return Response acknowledging receipt of the notice and disposal of the affected product.  If product was further distributed customers should contact those entities, advise them of the situation and provide them with a copy of this letter.  \nCustomers with questions were instructed to contact their Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).",
      "product_quantity": "2/50 test boxes",
      "distribution_pattern": "Nationwide Distribution including AZ, CA, DC, FL, IL, ME, NJ, NY, PA, VA, and VT.",
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        "device_name": "Device, General Purpose, Microbiology, Diagnostic",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.2660",
        "device_class": "1"
      }
    }
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}