{
  "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": "2026-08-15",
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      "cfres_id": "189491",
      "product_res_number": "Z-0195-2022",
      "event_date_initiated": "2021-09-22",
      "event_date_created": "2021-11-03",
      "recall_status": "Terminated",
      "event_date_terminated": "2022-08-02",
      "res_event_number": "88768",
      "product_code": "QKP",
      "product_description": "Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861",
      "code_info": "Lot # 44989001 - Exp. Date 2021-10-07, \nUDI # (01)00630414611846(10)44989001(17)20211007; \n\nLot # 60407003 - Exp. Date 2021-03-22, \nUDI # (01)00630414611846(10)60407003(17)20211112.",
      "firm_fei_number": "1219913",
      "recalling_firm": "Siemens Healthcare Diagnostics, Inc",
      "address_1": "333 Coney St",
      "city": "East Walpole",
      "state": "MA",
      "postal_code": "02032-1516",
      "additional_info_contact": "508-668-5000",
      "reason_for_recall": "Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.",
      "root_cause_description": "Device Design",
      "action": "On 9/22/2021, Siemens Healthineers issued Urgent Medical Device Correction notices to all US affected customers by FedEx beginning.  The customer distribution included all US\ncustomers that have received the Atellica IM and ADVIA Centaur CoV2Ag assays.\n\nActions to be Taken by the Customer\n- Discontinue use of and discard the kit lots listed in the notice.  \n- Please discuss this letter with your Medical Director.\n- Complete and return the Field Correction Effectiveness Check Form attached to this letter\nwithin 30 days.\n- To receive credit for discarded product, please complete and return the form provided.\n\nIf you have received any complaints of illness or adverse events associated with the\nproducts listed in the notice, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.\nPlease retain this letter with your laboratory records and forward this letter to those who may have received this product.",
      "product_quantity": "149 kits",
      "distribution_pattern": "US Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, ME, NC, NV, NY, OR, PA, PR, VA and VI.",
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