{
  "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": [
    {
      "country": "United States",
      "city": "Rochester",
      "address_1": "1000 Lee Road",
      "reason_for_recall": "Negative bias results when using VITROS VALP Reagent, GEN 25.",
      "address_2": "",
      "product_quantity": "9014  Total (U.S. = 6798;  OUS: U.S. = 2216)",
      "code_info": "Affected Lots/Expiry:  25-5263 2017-09-09;  25-5503 2018-01-06;  25-5727 2018-04-30;  25-5974 2018-08-14;  25-6067 2018-11-05;  25-6393   2019-04-05 (only non expired lot)  Unique Identifier:10758750006748",
      "center_classification_date": "20190219",
      "distribution_pattern": "Worldwide distribution- US (Nationwide) and countries of: Australia, Belgium, Bermuda, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands and United Kingdom.",
      "state": "NY",
      "product_description": "VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only.  CATALOG #(s):  6801710       INTENDED USE: For in vitro diagnostic use only. VITROS Chemistry Products VALP Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System to quantitatively measure valproic acid (VALP) concentration in human serum and plasma.",
      "report_date": "20190227",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Ortho-Clinical Diagnostics",
      "recall_number": "Z-0848-2019",
      "initial_firm_notification": "E-Mail",
      "product_type": "Devices",
      "event_id": "81806",
      "termination_date": "20200916",
      "more_code_info": "",
      "recall_initiation_date": "20181211",
      "postal_code": "14606",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}