{
  "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",
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      "cfres_id": "74781",
      "product_res_number": "Z-0502-2009",
      "event_date_initiated": "2008-10-20",
      "event_date_posted": "2008-12-18",
      "recall_status": "Terminated",
      "event_date_terminated": "2010-06-24",
      "res_event_number": "50125",
      "product_code": "GJS",
      "product_description": "STA Neoplastine CI Plus 10; Product Catalogue Number: 0667\nManufactured by Diagnostica Stago, Asnieres, France.",
      "code_info": "Lot 100439, Lot 101126, Lot 101601, Lot 100755, Lot 101231, Lot 101602, Lot 100975, Lot 101419, Lot 101726, Lot 100995, Lot 101420, Lot 101856, Lot 101002, Lot 101600, and Lot 101955.",
      "firm_fei_number": "2245451",
      "recalling_firm": "Diagnostica Stago, Inc.",
      "address_1": "5 Century Dr",
      "city": "Parsippany",
      "state": "NJ",
      "postal_code": "07054-4607",
      "additional_info_contact": "Umberto V. Parrotta\n973-631-1200 Ext. 2044",
      "reason_for_recall": "Internal investigation has determined the potential lack of homogeneity between product vials.",
      "root_cause_description": "Process control",
      "action": "Product Recall Notice letters were sent to all customers on October 20, 2008 vis US mail.  The letter stated the reason for the notice, the corrective action, and replacement process.  Customers are to confirm that they received the Recall Notice by completing the attached \"Product Recall Response Form\" and return by fax to the Regulatory Affairs Department at 973-867-6028 or 973-695-0095.  The firm is prepared to immediately implement the following corrective action: 1) perform QC testing in accordance to directions from the package insert on each vial and destroy vial and replace inventory if determined product was unsatisfactory OR 2) return inventory for replacement with new lots of inventory.  If customers have any questions or need any technical assistance, they are to call the DSI Hotline at 1-800-222-2624, option 1.",
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        "device_name": "Test, Time, Prothrombin",
        "medical_specialty_description": "Hematology",
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