{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "218462",
      "product_res_number": "Z-1585-2026",
      "event_date_initiated": "2026-02-05",
      "event_date_posted": "2026-03-19",
      "recall_status": "Open, Classified",
      "res_event_number": "98362",
      "product_code": "DAP",
      "k_numbers": [
        "K162227"
      ],
      "product_description": "Brand Name: STA Liatest D-Di \nProduct Name: STA Liatest D-Di \nModel/Catalog Number: REF 00515 \nProduct Description: in vitro diagnostic. The STA - Liatest D-Di kit is an assay for the quantitative determination of D-dimer in venous plasma for use on STA-R, STA Compact and STA Satellite analyzers by professional laboratory personnel.",
      "code_info": "Model/Catalog Number: REF 00515;\nUDIs: (1) (01)03607450005158(11)240630(17)250930(10)273015(241)00515, (2) (01)03607450005158(11)250325(17)260630(10)273127(241)00515, (3)(01)03607450005158(11)250416(17)260731(10)273275(241)00515, (4)(01)03607450005158(11)250527(17)260831(10)273567(241)00515, (5)(01)03607450005158(11)250618(17)260930(10)273681(241)00515, (6)(01)03607450005158(11)250716(17)261031(10)273808(241)00515, (7)(01)03607450005158(11)250716(17)261231(10)273808(241)00515, (8)(01)03607450005158(11)250909(17)261231(10)274108(241)00515 (9) (01)03607450005158(11)250326(17)260630(10)273128(241)00515, (10) (01)03607450005158(11)250429(17)260731(10)273606(241)00515, (11) (01)03607450005158(11)250709(17)261031(10)273805(241)00515, (12) (01)03607450005158(11)251007(17)270131(10)274219(241)00515;\nLot numbers: (1)273015, (2)273127, (3)273275, (4)273567, (5)273681, (6)273808, (7)273995, (8)274108, (9)273128, (10)273606, (11)273805, (12)274219;",
      "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": "Technical Hotline\n800-7250607",
      "reason_for_recall": "After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.",
      "root_cause_description": "Process change control",
      "action": "On February 5, 2026 QUALITY ALERT letters were emailed to customers.\nActions required: \n1. As the intended purpose of the kit is to exclude PE and DVT, and its sensitivity and negative predictive value remain unchanged, it is appropriate to continue utilizing the reagents.\n2. Please complete, sign and return the attached Acknowledgement Form by email, as directed on the form.\nIn the event that a patient experiences an adverse event with any medical device, you may report it to FDA; see the guidance document  Medical Device Reporting for User Facilities,  which is available on the FDA.gov website, for instructions.\nFor additional information, please contact Stago s 24/7 Hotline at 1-800-725-0607.",
      "product_quantity": "34000 units (28446 US, 5554 OUS)",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, Singapore, Guam, Japan, South Korea, and Russia.",
      "openfda": {
        "k_number": [
          "K013545",
          "K932657",
          "K890189",
          "K943787",
          "K920943",
          "K030687",
          "K032419",
          "K012755",
          "K070927",
          "K050544",
          "K020810",
          "K943571",
          "K063356",
          "K002642",
          "K862156",
          "K091916",
          "K162227",
          "K915503",
          "K030328",
          "K110303",
          "K141144",
          "K033491",
          "K022976",
          "K253985",
          "K915698",
          "K040882",
          "K002948",
          "K093626",
          "K160885",
          "K090264",
          "K041438",
          "K051597",
          "K112818",
          "K912876",
          "K050278",
          "K151534",
          "K013549",
          "K882944",
          "K000492",
          "K172903",
          "K974596",
          "K002706",
          "K974776",
          "K073042",
          "K040437",
          "K964728",
          "K042723",
          "K973819",
          "K080069",
          "K964718",
          "K992957",
          "K013544",
          "K003267",
          "K081732",
          "K872195",
          "K972696",
          "K022977",
          "K915203"
        ],
        "registration_number": [
          "9610746",
          "3008386529",
          "3013982035",
          "3003750284",
          "1217183",
          "9615037",
          "8020790",
          "9710666",
          "3013660430",
          "3002637618",
          "1181121",
          "2032900",
          "3005174594",
          "9610806",
          "1219738",
          "3003691680",
          "2517506",
          "3005360469",
          "2020726",
          "2245451",
          "2029372",
          "3037000637",
          "3006198300",
          "2246703",
          "3003030793",
          "2084025",
          "3003985394",
          "9610126"
        ],
        "fei_number": [
          "3005670738",
          "3008386529",
          "3013982035",
          "1000306617",
          "3004445302",
          "3003750284",
          "1217183",
          "3002806559",
          "3003565434",
          "3001644026",
          "3013660430",
          "3002637618",
          "3003261083",
          "1181121",
          "3005174594",
          "1000611339",
          "1219738",
          "3003691680",
          "2517506",
          "2020726",
          "2245451",
          "3037000637",
          "3006198300",
          "2246703",
          "3002806557",
          "3003030793",
          "2084025",
          "3003985394"
        ],
        "device_name": "Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.7320",
        "device_class": "2"
      }
    }
  ]
}