{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Rochester",
      "address_1": "601 Lee Rd Ny",
      "reason_for_recall": "VITROS TSH reagent lots have been found to generate higher than expected Calibrator level 2 signals on some customer systems. These Calibrator Level 2 responses cause a higher than expected frequency of customer generated calibration curves to fall outside of the calibration quality parameter measuring the gradient of the Customer Calibration Curve between Calibrator Level 2 and Calibrator Level 3.",
      "address_2": "",
      "product_quantity": "Lot #5470 (US=8570/OUS=537); Lot #5430 (US=0/OUS=9135); Lot #5178 (US=5178/OUS=4396)",
      "code_info": "Lot 5470, expiry date: 24-May-2018  Lot 5430, expiry date: 01-Mar-2018 (not distributed in the US.)  Lot 5178 was also affected by this issue, expired on 31-Mar-2017,",
      "center_classification_date": "20180411",
      "distribution_pattern": "Distributors were notified via letter.  Lot 5430 was not distributed in the US.  Lot 5178 was also affected by this issue, but this lot expired on 31-Mar-2017 so Ortho took no action on this lot.",
      "state": "NY",
      "product_description": "VITROS Immunodiagnostic Products TSH Reagent Pack",
      "report_date": "20180418",
      "classification": "Class III",
      "openfda": {},
      "recalling_firm": "Clinical Diagnostic Systems",
      "recall_number": "Z-1322-2018",
      "initial_firm_notification": "",
      "product_type": "Devices",
      "event_id": "79508",
      "termination_date": "20200908",
      "more_code_info": "",
      "recall_initiation_date": "20180111",
      "postal_code": "14652-0001",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}