{
  "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,
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  "results": [
    {
      "cfres_id": "185047",
      "product_res_number": "Z-0845-2021",
      "event_date_initiated": "2020-12-15",
      "event_date_created": "2021-01-12",
      "recall_status": "Terminated",
      "event_date_terminated": "2021-07-27",
      "res_event_number": "87019",
      "product_code": "CEK",
      "product_description": "VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concentration in serum and plasma using VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Systems\n\nProduct Code:\t6844293",
      "code_info": "All Current, Future and Past Lots  UDI: 10758750031771",
      "firm_fei_number": "2250051",
      "recalling_firm": "Ortho Clinical Diagnostics Inc",
      "address_1": "1001 US Highway 202",
      "city": "Raritan",
      "state": "NJ",
      "postal_code": "08869-1424",
      "additional_info_contact": "SAAME\n908-218-1300",
      "reason_for_recall": "Eltrombopag Interference  for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP Slides",
      "root_cause_description": "Device Design",
      "action": "Ortho-Clinical Diagnostics (Ortho) issued  customer letter (Ref. CL2018-308) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) on 15 Dec 2020 to all customers who received one of the affected products in the previous 18 months. Letter states reason for recall, health risk and action to take:\nComplete the enclosed Confirmation of Receipt form no later than insert date.\nPlease provide the enclosed communication  to customers who were shipped the affected products (listed above) from your facility within the last 18 months. Ortho has communicated with your customers that received drop shop product from our warehouse.\n\nForeign affiliates were informed by email on 15 Dec 2020 of the issue and instructed to notify their consignees of the issue and their required action until the updated the IFU is available.",
      "product_quantity": "US=9802; OUS: 1298 Total: 11,100",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution and the countries of AR, AU, BM, BR, CA, CL, CN, CO, CR, DO, EC, FR, FR, GT, HT, IN, JP, MX, PA, PE, PR, PY, SV.",
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        "medical_specialty_description": "Clinical Chemistry",
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