{
  "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": "203829",
      "product_res_number": "Z-0352-2024",
      "event_date_initiated": "2023-10-03",
      "event_date_posted": "2023-11-20",
      "recall_status": "Open, Classified",
      "res_event_number": "93282",
      "product_code": "GHH",
      "k_numbers": [
        "K062203"
      ],
      "product_description": "Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 plus), 08105618190 - (cobas c 303 and 503)",
      "code_info": "All Lots Affected.\n\nUDI: 04015630914593 - (cobas c 311, 501 and 502; INTEGRA 400 plus)\nUDI: 07613336133651 - (cobas c 303 and 503)",
      "firm_fei_number": "1823260",
      "recalling_firm": "Roche Diagnostics Operations, Inc.",
      "address_1": "9115 Hague Rd",
      "city": "Indianapolis",
      "state": "IN",
      "postal_code": "46256-1025",
      "additional_info_contact": "Roche Support Network Customer Support Center\n800-428-2336",
      "reason_for_recall": "Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.",
      "root_cause_description": "Under Investigation by firm",
      "action": "An URGENT MEDICAL DEVICE CORRECTION notification letter dated 10/3/23 was sent to customers.\n\nActions Required\n\" Roche recommends using citrated plasma for D-Dimer quantification until further notice.\n\" If your laboratory continues to use Li-heparin plasma for D-Dimer quantification, you are required to confirm all results between 0.5 g FEU/mL and 0.675 g FEU/mL with another D-Dimer method or with a citrated plasma sample.\n\" If your laboratory continues to use Li-heparin plasma for D-Dimer quantification and chooses to confirm results with another method, you may request credit for that testing from Roche. Contact your Roche sales representative to request reimbursement.\n\" Please complete all sections of the Recall Response Form (TP-01981) enclosed with this UMDC and fax it to 1-844-491-7776 or email it to roche5037@sedgwick.com.\n\" File this Urgent Medical Device Correction (UMDC) for future reference.\n\nCredit for Confirmatory Testing\nIf your laboratory continues to use Li-heparin plasma for D-Dimer quantification and chooses to confirm results with another method, you may request credit for that testing from Roche. Contact your Roche sales representative to request reimbursement.\n\nDistributor Actions Required\n\" Read the enclosed Customer UMDC TP-01986.\n\" Within 14 days from receipt of this UMDC, distribute a copy of the enclosed Customer UMDC\nTP-01986 to all customers to whom you have shipped the Tina-quant D-Dimer assays listed above in the last 2 years.\n\" Please complete all sections of the Distributor Recall Response Form (TP-01985) enclosed with this UMDC and fax it to 1-844-491-7776 or email it to roche5037@sedgwick.com.\n\" File this UMDC and the enclosed Customer UMDC for future reference.\n\nQuestions\nPlease contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.",
      "product_quantity": "5,263 kits",
      "distribution_pattern": "US Nationwide distribution.",
      "openfda": {
        "k_number": [
          "K972316",
          "K890422",
          "K042890",
          "K801841",
          "K921989",
          "K072288",
          "K905643",
          "K852520",
          "K890399",
          "K861973",
          "K880077",
          "K112120",
          "K062203",
          "K893961",
          "K011143",
          "K852176",
          "K812298",
          "K791358",
          "K021877",
          "K945642",
          "K030740",
          "K070453",
          "K993276",
          "K842277",
          "K852848",
          "K852512",
          "K872360",
          "K920668"
        ],
        "device_name": "Fibrin Split Products",
        "medical_specialty_description": "Hematology",
        "regulation_number": "864.7320",
        "device_class": "2",
        "registration_number": [
          "9612316",
          "8031673",
          "3003985394",
          "2084025",
          "2032900",
          "3013660430",
          "3029973107",
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          "3002637618",
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          "1181121",
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          "3014353045",
          "9710666",
          "2435505",
          "2032839",
          "9610529",
          "3003795116",
          "3013982035"
        ],
        "fei_number": [
          "3002808328",
          "3002806559",
          "3003985394",
          "1000206808",
          "2084025",
          "3013660430",
          "3029973107",
          "3006198300",
          "3002637618",
          "3002807710",
          "3004185580",
          "3002806560",
          "1181121",
          "2245451",
          "1000119795",
          "3004445302",
          "2517506",
          "3003565434",
          "3014353045",
          "2967",
          "3003795116",
          "3013982035"
        ]
      }
    }
  ]
}