{
  "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": "Norman",
      "address_1": "2700 Technology Pl",
      "reason_for_recall": "Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results",
      "address_2": "",
      "product_quantity": "875 units",
      "code_info": "Lot/Serial Numbers: L102802 and L103012",
      "center_classification_date": "20180710",
      "distribution_pattern": "On March 30, 2018, IMMY began issuing URGENT MEDICAL DEVICE RECALL notices to customers via email.  Customers were advised on how to recognize that the device has failed.      The following are Actions to be taken by the customer/user:  \" You may continue using the affected lots. Any testing performed on defective strips should be considered \u001cinvalid\u001d and should be repeated.  \" Please immediately notify lab personnel who are running the test to look for defective strips (as seen by fast wicking and/or very weak control lines).  \" Please immediately complete the Acknowledgement and Receipt Form even if you do not have any affected stock remaining and submit via email to: customerservice@immy.com.    \" Ensure relevant staff members are informed of this recall, including relevant clinicians.  \" If you have supplied any potentially affected product to another organization, please advise that organization of this recall and notify IMMY.    \" In case product is in transit, display this letter in a prominent place for one month.    Should you need a replacement kit, you will need to return your affected inventory. Instructions will be provided by customer service on how  to return kits to IMMY.    If you have any questions, contact IMMY\u0019s Quality Assurance Department by calling 1-405-360-4669 Monday through Friday 8:30 AM to 5:00 PM Central Standard Time.",
      "state": "OK",
      "product_description": "Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003    Product Usage: The CrAg Lateral Flow Assay is an immunochromatographic test system for the qualitative or semi-quantitative detection of the capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gattii) in serum and cerebral spinal fluid (CSF).  The CrAg Lateral Flow Assay is a prescription-use laboratory assay which can aid in the diagnosis of cryptococcosis.",
      "report_date": "20180718",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Immuno-Mycologics, Inc",
      "recall_number": "Z-2409-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "80284",
      "termination_date": "20200521",
      "more_code_info": "",
      "recall_initiation_date": "20180330",
      "postal_code": "73071-1127",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}