{
  "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": "Canton",
      "state": "MI",
      "country": "United States",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "77062",
      "recalling_firm": "Medtest Holdings, Inc.",
      "address_1": "5449 Research Dr",
      "address_2": "N/A",
      "postal_code": "48188-2261",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide Distribution",
      "recall_number": "Z-2316-2017",
      "product_description": "MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200)    HEC200  \" Sml amber glass vial with rubber stopper and black plastic screw cap.  \" 1 0 control vials per box, 12 cell foam insert.  HNC200  \" Sml amber glass vials with rubber stopper and green plastic screw cap.  \" 1 0 control vials per box, 12 cell foam insert.    Product Usage:  MedTest DX Controls Level 1 and 2 is lyophilized human based control sera for use in the quality control of diagnostic assays. Human sera can be supplied as an assayed serum for control of accuracy or as a precision serum for control reproductivity. Concentration are available in 2 levels, normal (HNC) and elevated (HEC).",
      "product_quantity": "10260 volume vials",
      "reason_for_recall": "MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200)  and Level 2 (HEC200) control values are outside of specification.",
      "recall_initiation_date": "20141023",
      "center_classification_date": "20170608",
      "termination_date": "20171117",
      "report_date": "20170614",
      "code_info": "HEC200:  \" 616UE, Mfr. Date 2013-02, Exp. 2017-01  \" 652UE, Mfr. Date 2013-07, Exp. 2017-07  \" 720UE, Mfr. Date 2014-08, Exp. 2018-07  HNC200:  \" 858UN, Mfr. Date 2013-07, Exp. 2018-07  \" 941 UN, Mfr. Date 2014-07, Exp. 2018-06"
    }
  ]
}