{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "168364",
      "product_res_number": "Z-0594-2019",
      "event_date_initiated": "2016-04-20",
      "event_date_created": "2018-12-10",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-02-15",
      "res_event_number": "81356",
      "product_code": "JPB",
      "product_description": "Cascade Abrazo c-ACT-LR Test Card\nIVD FOR IN VITRO DIAGNOSTIC USE\nStore at 2 to 8 C\nHELENA LABORATORIES\n003366\n12/13(2)\n\nFOR EXPORT ONLY\n\nThe Cascade Abrazo c-ACT-LR test cards are activated clotting time tests to be used with the Cascade Abrazo analyzer and are intended to monitor the effect of low to moderate heparin on coagulation in fresh whole blood.",
      "code_info": "Lot Codes: 1-15-5701 Model/Catalog Number: 5701",
      "firm_fei_number": "1618982",
      "recalling_firm": "Helena Laboratories, Inc.",
      "address_1": "1530 Lindbergh Dr",
      "city": "Beaumont",
      "state": "TX",
      "postal_code": "77707-4131",
      "additional_info_contact": "Dr. Jessica Hanka\n409-842-3714 Ext. 1177",
      "reason_for_recall": "Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected",
      "root_cause_description": "Device Design",
      "action": "On 04/20/2016 the firm, Helena Laboratories, contacted affected users via email, and then sent a \"WITHDRAWAL NOTIFICATION\" (dated April 25, 2016) on 04/27/2016.  The notification described the product, problem and actions to be taken. The firm instructed the customers/distributors to disposes of affected lot, as a preventive quality measure.\n\nThe Withdrawal Notification for Removal of Product from Inventory stated,\nThis lot is to be handled by Distributors, as follows:\n\n___ Prevent any shipments or scheduled demonstrations with this lot\n___ Remove this lot from Available Inventory and discard the cards\n___ Place cards in Quarantine  pending disposal\n___ Contact International Sales for credit and delivery of replacement cards\n\nVerify amount REMOVED FROM STOCK:  \n\nTotal number pulled: ____________________ Date _____________________________ \n\nThe following signifies written certification that this lot has not been sent to an end user:\n\nVerified by:  _____________________________________________________________\n\n\nPlease complete this form and return a copy to Helena Laboratories, via: FAX: 409-842-1874 or e-mail to jjones@helena.com   For questions, contact  Mgr., Technical Services at:  1 (409) 842-3714 ext. 1177.\n\n\n*Reason for removal: Some cards in this lot are experiencing variations in wave form, resulting in possible shorter, or longer, times than expected.   While this issue, if present, should be found via use of the Quality Control materials, due to its intermittent nature in the cards, this alone cannot be relied upon.",
      "product_quantity": "12 Kits",
      "distribution_pattern": "US Distribution to state of TX and internationally to:  Australia, Netherlands, Italy, and England.",
      "openfda": {
        "device_name": "Hemoglobin M",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.7415",
        "device_class": "2"
      }
    }
  ]
}