{
  "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": "Tarrytown",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "75798",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "address_1": "511 Benedict Ave",
      "address_2": "N/A",
      "postal_code": "10591-5005",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution-US (nationwide)and the following countries: Afghanistan, Albania, Algeria, Argentina, Aruba, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia Herzeg, Brazil, British Guyana, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Dominican Rep., Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Great Britain, Grenada, Guatemala, Honduras, Hungary, Iceland,  India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Kosovo, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mexico,  Netherlands, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines,  Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Serbia, Slovakia, Spain, South Africa, South Korea, Suriname, Switzerland, Syria, Taiwan, Tadjikistan, Thailand, Trinidad, Tobago, Tunisia, Turkey, Turkmenistan, United Arab Emirates, Uruguay, Uzbekistan, Venezuela, and Vietnam.",
      "recall_number": "Z-0884-2017",
      "product_description": "IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number LKPTS1, Siemens Material Number (SMN) 10706279 (US); Catalog Number LKPS1, SMN 10380960 and Catalog Number LKPS5, SMN 10380949 (OUS); IVD --- Origin: UK Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL554EL UK    For in vitro diagnostic use with the IMMULITE /IMMULITE 1000/IMMULITE 2000/2000 XPi Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients.",
      "product_quantity": "4705 kits (US: 390 kits; OUS: 4315 kits)",
      "reason_for_recall": "Siemens Healthcare Diagnostics has confirmed that the IMMULITE/ IMMULITE 1000 Systems PSA assays are not meeting the current High-dose Hook Effect expectation in the Instructions for Use.",
      "recall_initiation_date": "20161118",
      "center_classification_date": "20161222",
      "termination_date": "20180607",
      "report_date": "20161228",
      "code_info": "All lots  LKPS1/LKPS5 - Lots 443, 445, 446  LKPTS1 - Lot D116"
    }
  ]
}