{
  "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": "2026-08-13",
    "results": {
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  "results": [
    {
      "cfres_id": "148884",
      "product_res_number": "Z-0090-2017",
      "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": "KHP",
      "k_numbers": [
        "K955286"
      ],
      "product_description": "VITROS Chemistry Products LAC Slides, REF/Product Codes 843 3880 (300 slides per sales unit) and 815 0112 (90 slides per sales unit), Unique Device Identifier Nos. 10758750004911 and 10758750004454, Rx ONLY, IVD ---  \nFor in vitro diagnostic use only. VITROS Chemistry Products LAC Slides quantitatively measure lactate (LAC) concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.",
      "code_info": "Current/In-date GENs 30, 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: 32,081 sales units; Foreign: 29,932 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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        "device_name": "Acid, Lactic, Enzymatic Method",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1450",
        "device_class": "1"
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