{
  "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": "148886",
      "product_res_number": "Z-0092-2017",
      "event_date_initiated": "2016-08-11",
      "event_date_created": "2016-10-17",
      "recall_status": "Terminated",
      "event_date_terminated": "2018-06-11",
      "res_event_number": "74950",
      "product_code": "KNK",
      "k_numbers": [
        "K932728"
      ],
      "product_description": "VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides per sales unit),  Unique Device Identifier No. 10758750000340, Rx ONLY, IVD ---\n For in vitro diagnostic use only.",
      "code_info": "Current/In-date GENs 26, 27, 28, 29, 31",
      "firm_fei_number": "1000136573",
      "recalling_firm": "Ortho-Clinical Diagnostics",
      "address_1": "100 Indigo Creek Dr",
      "city": "Rochester",
      "state": "NY",
      "postal_code": "14626-5101",
      "additional_info_contact": "Ms. Jennifer Paine\n908-218-8776",
      "reason_for_recall": "Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere with VITROS GLU, LAC, TRIG, and URIC Slides assays.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Ortho-Clinical Diagnostics sent an URGENT PRODUCT CORRECTION Letter (Ref. CL2016-152) dated August 11, 2016 via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/or US Postal Service Priority Mail (for PO Boxes only) to all customers who could order and use affected product to inform them that new interferant were identified for GLU, LAC, TRIG and URIC Slides which may cause biased results. Foreign affiliates were informed by e-mail on August 11, 2016, of the issue and instructed to notify their consignees of the issue.  For questions, please contact our Ortho CareTM Technical Solutions Center at 1-800-421-3311.\nFor questions regarding this recall call 908-218-8776.",
      "product_quantity": "US: 18,749 sales units; Foreign: 94,928 sales units",
      "distribution_pattern": "Worldwide Distribution - US (Nationwide) Puerto Rico and Bermuda), Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy,  Japan, Mexico, Republic of Panama, Poland, Singapore, Spain, and Venezuela.",
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