{
  "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": [
    {
      "country": "United States",
      "city": "Tarrytown",
      "address_1": "511 Benedict Ave",
      "reason_for_recall": "Multiple customers reported seeing an increase in imprecision with some patients resulting in high % CVs with the IMMULITE 2000/2000XPi CMV (IgM) assay starting with reagent lots 259 and above.",
      "address_2": "",
      "product_quantity": "US: 5 kits; Foreign: 372 kits",
      "code_info": "UDI 00630414985718/Catalog # LKCM1(D): Kit lot D0330;   UDI 00630414963747/Catalog # LKCM1: Kit lots 0330, 0331",
      "center_classification_date": "20161027",
      "distribution_pattern": "Worldwide distribution- US (Nationwide) and countries of: United Arab Emirates, Afghanistan, Angola, Argentina, Australia, Bangladesh, Belgium, Bulgaria, Bahrain, Bolivia, Brazil, Belarus, Switzerland, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Germany, Dominican Republic, Algeria, Ecuador, Egypt, Spain, France, Great Britain, Greece, Guatemala, Honduras, Hungary, India, Iraq, Italy, Jordan, Canary Islands, Kyrgyzstan, Rep. Korea (S), Kazakhstan, Lebanon, Lithuania, Luxembourg, Latvia, Macedonia, Mexico, Malaysia, Nicaragua, Netherlands, Norway, Nepal, Peru, Pakistan, Poland, Portugal, Paraguay, Qatar, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, El Salvador, Syria, Turkmenistan, Tunisia, Turkey, Uruguay, Uzbekistan, Vietnam, Serbia,and South Africa.",
      "state": "NY",
      "product_description": "IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 tests (US), Siemens Material Number (SMN) 10370301 (US), Unique Device Identification Number (UDI) 00630414985718 (US); and  REF/Catalog Number LKCM1 - 100 tests (OUS); SMN 10381296 (OUS), UDI 00630414963747 (OUS); IVD --- Made in UK Siemens Healthcare Diagnostics Products Ltd., Glyn Rhonwy, Llanberis, Gwynedd, LL55 4EL UK    For in vitro diagnostic use with the IMMULITE Systems Analyzers for the qualitative detection of IgM antibodies to Cytomegalovirus (CMV) in human serum or plasma (EDTA or heparinized), as an aid in the determination of an acute CMV infection.",
      "report_date": "20161102",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc.",
      "recall_number": "Z-0319-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "75090",
      "termination_date": "20180607",
      "more_code_info": "",
      "recall_initiation_date": "20160830",
      "postal_code": "10591-5005",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}