{
  "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": "East Walpole",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "72968",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc",
      "address_1": "333 Coney St",
      "address_2": "N/A",
      "postal_code": "02032-1516",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide - US Nationwide including Puerto Rico, OUS: Albania, Algeria, Angola, Armenia, Austria, Bahrain, Belarus, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Great Britain, Greece, Hungary, Iceland, Iraq, Italy, Jordan, Kazakhstan, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malta, Morocco, Netherlands, Norway, Oman, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Tunisia, Turkey, Turkmenistan, Unit.Arab Emir., Vatican, AR,  AU,  BD, BR, CA, CL, CN, CO, DO, EC, GT, HK, ID, IL, IN, JP, KR, LK, MM, MX, MY, NI, NP, NZ, PE, PH, PY, SA, SG, TH, TW, UY, VN and ZA.",
      "recall_number": "Z-0754-2016",
      "product_description": "ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit) and Catalog Number: 02676506/SMN 10310293 (500 test kit)    Product Usage:  This in vitro diagnostic assay is intended to quantitatively measure prostate-specific Antigen (PSA) in human serum using the ADVIA Centaur/XP/XPT/CP Systems.",
      "product_quantity": "55,754 kits",
      "reason_for_recall": "PSA assay is not meeting the High Dose Hook Effect expectation in the Instructions for Use (IFU).",
      "recall_initiation_date": "20151229",
      "center_classification_date": "20160204",
      "termination_date": "20191129",
      "report_date": "20160210",
      "code_info": "SMN 10310292-100 test kits  Lot# UDI #  54637263 0063041420300354637263160223  55304263 0063041420300355304263160223  56249264 0063041420300356249264160327  76727264 0063041420300376727264160327  00825265 0063041420300300825265160424  92416265 0063041420300392416265160424  99151265 0063041420300399151265160424  12970266 0063041420300312970266160721  14158266 0063041420300314158266160721  23016266 0063041420300323016266160721  28881266 0063041420300328881266160721  40776268 0063041420300340776268160922    SMN 10310293-500 test kits  Lot# UDI #  54448263 0063041420299054448263160223  55171263 0063041420299055171263160223  56171264 0063041420299056171264160327  77560264 0063041420299077560264160327  92415265 0063041420299092415265160424  96996265 0063041420299096996265160424  12971266 0063041420299012971266160721  13429266 0063041420299013429266160721  19651266 0063041420299019651266160721  27278266 0063041420299027278266160721  35089266 0063041420299035089266160721  39805268 0063041420299039805268160922  50851268 0063041420299050851268160922",
      "more_code_info": ""
    }
  ]
}