{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "East Walpole",
      "address_1": "333 Coney St",
      "reason_for_recall": "ADVIA Centaur Prolactin Assay and FSH, Calibrator B  fails the analytical sensitivity stated in the IFU for lots below 40",
      "address_2": "",
      "product_quantity": "15,445 kits",
      "code_info": "US:  2 Pack  Ref: 00649625:  Lot Numbers/Exp Date: Dec 2, 2012:  78813A30  79982A30  81013A30  82021B30  82767B30  83453C30  85447D30  87319A40   Exp Date:April 9, 2013  85598A40  85708A40  86098A40  87319A40  87979B40  88809B40  89351C40  91750C40  (6 pack) Ref. 00652707:  Lot Numbers/Exp Date: Dec 2 2012  79354A30  80802A30  81892B30  82815B30  83741D30  84186A40 Exp. Date April, 8, 2013  85599A40  86191A40  88102B40  89717C40  91383C40  (6 Pack) Ref: 00654254   79714A30  Exp Date Dec 2, 2012  82370A30  84274A30  85512E30  OUS:  2 pack REF: 00650577    78319A29 Exp Dec 2, 2102  78487A29  79024A29  79403A29  79770B29  79981B29  82935B29  85735C29  00654130    Ref: 00654130 (6 pack)  78321A29  Exp Dec 2,2102  79197A29  83314C29",
      "center_classification_date": "20120920",
      "distribution_pattern": "Worldwide Distribution - US Nationwide and the countries of: Canada, Argentina, Australia, Bangaldesh,Brazil, Chile, China, Columbia, Croatia, Ecuduar, Egypt, Hong Kong, India, Israel,Japan,  Korea, Maylasia, New Zealand, Mexico, Peru, Philipines, Pakistan, Saudia Arabia, Singapore, Thailand, Taiwan, Viet Nam, South Africa and UK.",
      "state": "MA",
      "product_description": "ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B    US: Calibrator B 00652707 (6 pack) or 00649625 (2 pack )  OUS:OUS: 2 pack REF: 00650577  and Ref: 00654130 (6 pack)    Product Usage:  ADVIA Centaur CP FSH assay: For in vitro diagnostic use in the quantitative determination of follicle-stimulating hormone (FSH) in serum using the ADVIA Centaur and ADVIA Centaur XP systems",
      "report_date": "20120926",
      "classification": "Class III",
      "openfda": {},
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc",
      "recall_number": "Z-2410-2012",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "62897",
      "termination_date": "20140226",
      "more_code_info": "",
      "recall_initiation_date": "20120807",
      "postal_code": "02032-1516",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}