{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Rochester",
      "state": "NY",
      "country": "United States",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "75692",
      "recalling_firm": "Ortho-Clinical Diagnostics",
      "address_1": "513 Technology Blvd",
      "address_2": "N/A",
      "postal_code": "14626-3601",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico, and to the countries of :  Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.",
      "recall_number": "Z-0864-2017",
      "product_description": "VITROS CRP Slides: 1)  VITROS¿ Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2) , VITROS¿ Chemistry Products CRP Slides (90 slides per sales unit), Catalog # 1926740",
      "product_quantity": "124,063 units",
      "reason_for_recall": "CRP samples diluted using VITROS Chemistry Products Specialty Diluent, VITROS Chemistry Products FS Diluent Pack 3, or a sample with a low concentration of CRP had positively biased results if the endogenous level of CRP in the diluent is not subtracted from the final result.  The IFUs do not provide specific instructions for how to account for endogenous CRP in the diluent when calculating the sample result.  Ortho\u0019s diluents used to dilute samples containing CRP are manufactured using human plasma based fluids that contain endogenous CRP.  Without accounting for the CRP in the diluent and removing its contribution from the result, the reported result will include the CRP present in both the sample and diluent, possibly leading to positively biased results.",
      "recall_initiation_date": "20161026",
      "center_classification_date": "20161221",
      "termination_date": "20180622",
      "report_date": "20161228",
      "code_info": "Affected Generations (GENs): 3, 11, 12, 30 through 36"
    }
  ]
}