{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Raritan",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "90047",
      "recalling_firm": "Ortho-Clinical Diagnostics, Inc",
      "address_1": "1001 Us Highway 202",
      "address_2": "N/A",
      "postal_code": "08869-1424",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution: US (Nationwide) OUS (Foreign): Australia Bermuda Brazil Canada L3R 4G5  Chile China Colombia Denmark France Germany India Italy Japan Mexico Netherlands Norway Portugal Russia Singapore  Spain Sweden United Kingdom",
      "recall_number": "Z-1113-2022",
      "product_description": "VITROS Immunodiagnostic Products LH Reagent Pack  Product Code: 1350198",
      "product_quantity": "1575 units total:\t1183 US; 392 OUS",
      "reason_for_recall": "Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and patient samples at the low end of the Measuring (Reportable) Range when using VITROS FSH, LH and Prol Reagent. Calibration failures, driven by imprecision observed with Calibrator Level 1.",
      "recall_initiation_date": "20220325",
      "center_classification_date": "20220518",
      "report_date": "20220525",
      "code_info": "Until further notice, future lots will also be affected. UDI: 10758750008902 Affected Lot Number/ Expiration Date: 1910 14-AUG-2022 1920 19-SEP-2022 1930 19-OCT-2022 1940 31-OCT-2022 1950 28-JAN-2023 1960 31-JAN-2023",
      "more_code_info": ""
    }
  ]
}