{
  "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",
    "results": {
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      "product_res_number": "Z-0108-2020",
      "event_date_initiated": "2019-08-28",
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      "recall_status": "Terminated",
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      "res_event_number": "83758",
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      "code_info": "All serial numbers",
      "firm_fei_number": "1823260",
      "recalling_firm": "Roche Diagnostics Operations, Inc.",
      "address_1": "9115 Hague Rd",
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      "state": "IN",
      "postal_code": "46256-1025",
      "additional_info_contact": "Roche Support Network Customer Support Center\n800-428-2336",
      "reason_for_recall": "Tina-quant Soluble Transferrin Receptor (STFR) Assays   Updated Claims for Rheumatoid Factors Interference",
      "root_cause_description": "Under Investigation by firm",
      "action": "Roche issued notification to consignees by Urgent Medical Device Correction (TP-00754) sent via UPS (signature required) on 8/28/19. The UMDC will also be available on diagnostics.roche.com. The letter identifies the problem, risk to health and action to take: Be aware of new interference claims that are listed in this UMDC and that the rhEPO Therapy Monitoring Statement will be removed from the Method Sheets. The UMDC will serve as intermediate labeling until the updated method sheets are available. Complete all sections of the enclosed fax form. Contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions if you have questions",
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