{
  "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": "184441",
      "product_res_number": "Z-0634-2021",
      "event_date_initiated": "2020-11-06",
      "event_date_created": "2020-12-17",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-10-18",
      "res_event_number": "86745",
      "product_code": "DCN",
      "k_numbers": [
        "K083444"
      ],
      "product_description": "Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative determination of CRP in human serum and plasma on Roche automated clinical chemistry analyzers.",
      "code_info": "CRPL3 - lot 42402301",
      "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": "Roche confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the Tina-quant C-Reactive Protein Gen. 3 on the cobas c701 and 702 modules. A discoloration (yellow color) was observed and is the  result of cross contamination between the R1 and R3 reagents.",
      "root_cause_description": "Process control",
      "action": "On November 6, 2020, the firm mailed customers Urgent Medical Device Correction letters. Customers were informed that the present communication serves as an update to previous UMDCs sent on 9/11/2019, 12/18/2019, and 8/27/2020, in that it includes the new product and lot number listed above.\n\nCustomer Instructions:\n\n\" Discontinue use and discard any remaining affected product in your inventory according to your local waste\nguidelines.\n\" Refer to the Product Replacement section on page 2 of the UMDC for product replacement information.\n\" Complete all sections of the enclosed faxback form (TP-01128) and fax or email it according to the\ninstructions on the form even if you are not requesting product replacement.\n\" If your facility has distributed the affected product to another site, please ensure this UMDC is provided to\nthat site.\n\" File this UMDC for future reference.\n\nPlease contact the Roche Support Network Customer Support Center 24 hours a day, seven days a week at\n1-800-428-2336 if you have questions about this recall.",
      "product_quantity": "699 units",
      "distribution_pattern": "US Nationwide distribution including in the states of AL, CA, FL, \nGA, HI, IA, IL, IN, KY, MA, MD, MI, MN, MO, NJ, NY, OH, PA, SC, TN, TX, VA.",
      "openfda": {
        "k_number": [
          "K883515",
          "K854819",
          "K040030",
          "K021572",
          "K955042",
          "K003400",
          "K062981",
          "K831465",
          "K892231",
          "K811374",
          "K882374",
          "K831364",
          "K021882",
          "K935075",
          "K896272",
          "K232624",
          "K161982",
          "K903853",
          "K860679",
          "K002918",
          "K771139",
          "K932180",
          "K003419",
          "K991372",
          "K091052",
          "K902593",
          "K172868",
          "K083444",
          "K904497",
          "K885001",
          "K073277",
          "K061825",
          "K083412",
          "K812881",
          "K032336",
          "K974429",
          "K003342",
          "K872539",
          "K821388",
          "K180099",
          "K221119",
          "K083040",
          "K020603",
          "K880728",
          "K192072",
          "K113809",
          "K011855",
          "K990825",
          "K834584",
          "K810862",
          "K954537",
          "K012337",
          "K834390",
          "K003372",
          "K050713",
          "K841265",
          "K840699",
          "K771535",
          "K171498",
          "K855057",
          "K021757",
          "K910535",
          "K072658",
          "K011958",
          "K910686",
          "K790716",
          "K821413",
          "K831362",
          "K030899",
          "K022690"
        ],
        "device_name": "System, Test, C-Reactive Protein",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5270",
        "device_class": "2",
        "registration_number": [
          "2250030",
          "2432235",
          "1649661",
          "1641328",
          "2020726",
          "2050012",
          "3012471076",
          "3029973107",
          "9610806",
          "3006198300",
          "1616487",
          "2029372",
          "1036362",
          "3014607865",
          "2939693",
          "9610126",
          "2085064",
          "3002806944",
          "9680746",
          "9610987",
          "3009491259",
          "2517506",
          "1832216",
          "3014353045",
          "2032682",
          "9614373",
          "3005174594",
          "2435505",
          "2050010",
          "3004493545",
          "9610529",
          "3010825766",
          "3003795116"
        ],
        "fei_number": [
          "2250030",
          "2432235",
          "3002806559",
          "1641328",
          "2020726",
          "1000206808",
          "2050012",
          "3012471076",
          "3029973107",
          "1000306617",
          "3006198300",
          "3001451797",
          "1616487",
          "3002807710",
          "1036362",
          "3014607865",
          "2939693",
          "3002806560",
          "1000135102",
          "3002806944",
          "1000119795",
          "3003952975",
          "3009491259",
          "2517506",
          "1832216",
          "3002808340",
          "3014353045",
          "3001644026",
          "3005174594",
          "2050010",
          "3004493545",
          "3010825766",
          "3003795116"
        ]
      }
    }
  ]
}