{
  "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": "East Walpole",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86383",
      "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": "US Nationwide distribution.",
      "recall_number": "Z-0115-2021",
      "product_description": "Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes:  (01)00630414599151(10)98034139(17)20210130 and (01)00630414599151(10)32478139(17)20210130    Atellica IM HER-2/neu (H2n) calibrator, 2 Pack, Catalog No. SMN 10995592, UDI Code  (01)00630414599168(10)22695A49(17)20201211    ADVIA Centaur HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10308994, UDI codes :  (01)00630414471235(10)43157138(17)20210130  (01)00630414471235(10)81653138(17)20210130  (01)00630414471235(10)99728138(17)20210130  (01)00630414471235(10)24043138(17)20210130  (01)00630414471235(10)32477138(17)20210130    Advia Centaur Systems HER-2/neu (H2n) calibrator, 2 Pack, Catalog No. SMN 10308993, UDI Codes:  (01)00630414471228(10)64661A48(17)20201112  (01)00630414471228(10)81211A48(17)20201112  (01)00630414471228(10)91743A48(17)20201112  (01)00630414471228(10)22124A49(17)20201211       Product Usage: This product is intended to be used for in vitro diagnostic use in calibrating the ADVIA Centaur systems HER-2/neu assay.",
      "product_quantity": "Atellica IM H2n Assay =135 kits; Atellica IM H2n Calibrator = 46 kits;  ADVIA Centaur Assay = 1,823 kits; ADVIA Centaur calibrator = 161 kits",
      "reason_for_recall": "Siemens confirmed that the Upper Limit of Normal (ULN) as claimed in the Instructions for Use (IFU) was no longer achieved. This can potentially result in false positive or false negative results.",
      "recall_initiation_date": "20200825",
      "center_classification_date": "20201016",
      "termination_date": "20230310",
      "report_date": "20201028",
      "code_info": "Atellica IM HER-2/neu Assay 50 Test Kit:  Siemens Material Number (SMN) 10995591; EXP Date 2021-01-30;  Lot # 98034139 w/ UDI (01)00630414599151(10)98034139(17)20210130;  Lot # 32478139 w/ UDI (01)00630414599151(10)32478139(17)20210130    Atellica IM HER-2/neu Calibrator (2 pack):  SMN 10995592; EXP Date 2020-12-11;   Lot # 22695A49; UDI (01)00630414599168(10)22695A49(17)20201211    ADVIA Centaur HER-2 Assay 50 Test Kit:  SMN 10308994; EXP Date 2021/01/30;  Lot # 43157138 w/ UDI (01)00630414471235(10)43157138(17)20210130 ;  Lot# 81653138 w/ UDI (01)00630414471235(10)81653138(17)20210130 ;  Lot# 99728138 w/ UDI (01)00630414471235(10)99728138(17)20210130 ;  Lot # 24043138 w/ UDI (01)00630414471235(10)24043138(17)20210130 ;  Lot #32477138 w/ UDI  (01)00630414471235(10)32477138(17)20210130 ;    ADVIA Centaur HER-2/neu Calibrator (2 pack):  SMN 10308993; EXP Date 2020-11-12  Lot # 64661A48 w/ UDI (01)0063041447(10)64661A48(17)20201112  Lot # 81211A48 w/ UDI (01)0063041447(10)81211A48(17)20201112  Lot# 91743A48  w/ UDI (01)0063041447(10)91743A48(17)20201112    EXP Date 2020-12-11;   Lot # 22124A49 w/ UDI (01)0063041447(10)22124a49(17)20201112"
    }
  ]
}