{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "168397",
      "product_res_number": "Z-0476-2019",
      "event_date_initiated": "2018-10-08",
      "event_date_created": "2018-11-17",
      "recall_status": "Terminated",
      "event_date_terminated": "2022-10-13",
      "res_event_number": "81376",
      "product_code": "MRR",
      "k_numbers": [
        "K041720"
      ],
      "product_description": "VITROS Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC)\nProduct Code: 6801728\nUDI (10758750006793)",
      "code_info": "Lot Numbers:   1517-26-6396  (expires 6-Nov-2018)  1517-26-6582  (expires 2-Feb-2019)  1517-26-6639 (expires 2-Feb-2019)  1517-27-6808 (expires 7-May-2019)",
      "firm_fei_number": "1000136573",
      "recalling_firm": "Ortho-Clinical Diagnostics",
      "address_1": "100 Indigo Creek Dr",
      "city": "Rochester",
      "state": "NY",
      "postal_code": "14626-5101",
      "reason_for_recall": "VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results",
      "root_cause_description": "Under Investigation by firm",
      "action": "Ortho Clinical Diagnostics issue the customer notification on October 8, 2018,  provides information regarding the potential for biased results when using VITROS dLDL Reagent, Generations (GENs) 26 and 27. Actions to take:\nFor GEN 26: Discontinue using GEN 26 and switch to an alternate GEN of product as soon as possible. Please specify full or partial sales units remaining and indicate credit or replacement on your Confirmation of Receipt form.\n\" For GEN 27: Install ADD DRV 6003 on your VITROS System upon receipt. Following a successful recalibration, resume using VITROS dLDL Reagent, GEN 27 remaining in your inventory.\n\" Complete the Confirmation of Receipt form and return by October 22, 2018.\nQuestions contact our Ortho Care\" Technical Solutions Center at 1-800-421-3311",
      "product_quantity": "5850 units",
      "distribution_pattern": "Nationwide\nForeign: \nAustralia\nBelgium\nBermuda, HM11\nBrazil\nCanada L3R 4G5 \nChile\nChina\nColombia\nDenmark\nFrance\nGermany\nIndia\nItaly\nJapan\nMexico\nNorway\nPoland\nPortugal\nRussia\nSingapore \nSpain\nSweden\nThe Netherlands\nUnited Kingdom",
      "openfda": {
        "k_number": [
          "K161691",
          "K955904",
          "K091333",
          "K982529",
          "K924674",
          "K040693",
          "K051121",
          "K991733",
          "K063841",
          "K893740",
          "K022772",
          "K964064",
          "K982848",
          "K943150",
          "K981978",
          "K993741",
          "K043264",
          "K041720",
          "K090734",
          "K984107",
          "K982271",
          "K964063",
          "K020575",
          "K210801",
          "K992766",
          "K041927",
          "K241800",
          "K981303",
          "K020724",
          "K014103",
          "K012287"
        ],
        "registration_number": [
          "3017379203",
          "2247288",
          "2030861",
          "3010891909",
          "3003356736",
          "1616487",
          "2250051",
          "3006198300",
          "3007662974",
          "2050012",
          "9610126",
          "1319808",
          "3002642396",
          "3003539867",
          "1827821",
          "3006716639",
          "3011080315",
          "3000308930",
          "2050010",
          "3003522182",
          "1220972",
          "3010825766",
          "3014325803",
          "1319681",
          "3000148879",
          "2085064",
          "3003871639",
          "3003419906",
          "1832216",
          "2432235",
          "3012963943",
          "8020316",
          "2517506",
          "3004493545",
          "3003795116",
          "3013660430",
          "9610529"
        ],
        "fei_number": [
          "3017379203",
          "3002806809",
          "3002806560",
          "3010891909",
          "3003356736",
          "1616487",
          "3002806559",
          "2250051",
          "3006198300",
          "3007662974",
          "1000305841",
          "3002642396",
          "1827821",
          "3006716639",
          "3011080315",
          "3000308930",
          "2050010",
          "3003522182",
          "1220972",
          "3010825766",
          "3014325803",
          "1000122044",
          "3000148879",
          "3006769061",
          "1000135102",
          "3003871639",
          "3003419906",
          "1832216",
          "2432235",
          "3012963943",
          "2517506",
          "3004493545",
          "3003795116",
          "1000136573",
          "3013660430",
          "3000215862",
          "2050012"
        ],
        "device_name": "System, Test, Low Density, Lipoprotein",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1475",
        "device_class": "1"
      }
    }
  ]
}