{
  "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": {
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      "status": "Terminated",
      "city": "Indianapolis",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81814",
      "recalling_firm": "Roche Diagnostics Corporation",
      "address_1": "9115 Hague Rd",
      "address_2": "N/A",
      "postal_code": "46256-1025",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution.",
      "recall_number": "Z-1125-2019",
      "product_description": "cobas c 111 with ISE analyzers analyzer used in the following assays:  a)Creatinine plus ver.2   Catalog Number: 05401470190;    b)Triglycerides  Catalog Number:  04657594190 - Product Usage: Tina-quant Apolipoprotein A-1 ver.2 A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders and atherosclerosis Tina-quant Albumin Gen.2 Immunoturbidimetric assay for the quantitative, in vitro determination of albumin in human urine, serum, plasma, and CSF on Roche/Hitachi cobas c systems",
      "product_quantity": "137 units",
      "reason_for_recall": "COBAS INTEGRA¿ 400 plus and cobas c 111 analyzers  Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests  Due to Carry-over",
      "recall_initiation_date": "20181214",
      "center_classification_date": "20190410",
      "termination_date": "20200904",
      "report_date": "20190417",
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