{
  "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-1112-2022",
      "product_description": "VITROS Immunodiagnostic Products FSH Reagent Pack- IVD  1931922",
      "product_quantity": "2502 total: 2154\tUS; 348 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:  10758750000302 Affected Lot Number/ Expiration Date: 3100  01-MAR-2022; 3111  25-MAR-2022; 3120  04-APR-2022; 3130  25-APR-2022; 3140  10-MAY-2022; 3145  10-MAY-2022; 3150  30-MAY-2022; 3160  09-JUN-2022; 3170  22-JUN-2022;  3180 02-AUG-2022; 3190 16-AUG-2022; 3200  06-SEP-2022; 3210  12-SEP-2022.",
      "more_code_info": ""
    }
  ]
}