{
  "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": "Terminated",
      "city": "Marburg",
      "state": "N/A",
      "country": "Germany",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "83183",
      "recalling_firm": "DRG Instruments GmbH",
      "address_1": "Frauenbergstr. 18",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide Distribution - US Nationwide CA, MI  Foreign:  Canada, Brazil, China, Poland",
      "recall_number": "Z-2159-2019",
      "product_description": "DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva  Catalog # SLV-3013     Product Usage:  The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of Testosterone in human Saliva. Testosterone levels are measured in fertility studies in men and women. Fertility problems are not diagnosed on the outcome of Testosterone alone but accompanied by other diagnostic means",
      "product_quantity": "38 kits",
      "reason_for_recall": "Salivary assay may observe a higher percentage of samples with 0 pg/ml testosterone or results which are too low. Saliva samples in the low measuring range of the kit(< 50 pg/ml) were assayed significantly lower",
      "recall_initiation_date": "20190521",
      "center_classification_date": "20190805",
      "termination_date": "20200529",
      "report_date": "20190814",
      "code_info": "Lot Numbers: 66K118, 66K019"
    }
  ]
}