{
  "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": [
    {
      "country": "United States",
      "city": "Indianapolis",
      "address_1": "9115 Hague Rd",
      "reason_for_recall": "Abnormally high INR test results with the affected CoaguChek test strips",
      "address_2": "",
      "product_quantity": "1,163,952 boxes",
      "code_info": "1) Catalog Number 04625375160  Lot Numbers authorized for use within the USA:   28124111  28124121  28631911  28631921  28631924  28632021  28632213  28632312  28632412  29415113  29415123  29494221  29494312  29494613  29494711  29778721  29779012  29779213  29779214  30497213  30497311  30497413  30497423  30497515  31404314  31404821  32264116  32264212  32264316  32264317  32264411  32264421  33045913  33046011  33046113  33046312  33046314  33046321  33046322  33449612  33449712  33449723  33449817      2) Catalog Number 04625374160  Lot Numbers authorized for use within the USA:   28124111  28124121  28631911  28631921  28631924  28632021  28632213  28632312  28632412  29415113  29415123  29494221  29494312  29494613  29494711  29778721  29779012  29779213  29779214  30497213  30497311  30497413  30497423  30497515  31404314  31404821  32264116  32264212  32264316  32264317  32264411  32264421  33045913  33046011  33046113  33046312  33046314  33046321  33046322  33449612  33449712  33449723  33449817    3) Catalog Number: 07797826160  Lot Numbers authorized for use within the USA:   28124111  28124121  28631911  28631921  28631924  28632021  28632213  28632312  28632412  29415113  29415123  29494221  29494312  29494613  29494711  29778721  29779012  29779213  29779214  30497213  30497311  30497413  30497423  30497515  31404314  31404821  32264116  32264212  32264316  32264317  32264411  32264421  33045913  33046011  33046113  33046312  33046314  33046321  33046322  33449612  33449712  33449723  33449817",
      "center_classification_date": "20181102",
      "distribution_pattern": "Nationwide",
      "state": "IN",
      "product_description": "CoaguChek¿ XS System Prothrombin time test:  CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160;  CoaguChek XS PT Test 6 Strips, Catalog Number: 04625374160;  CoaguChek XS PT Test 24 Tests, Catalog Number: 07797826160;",
      "report_date": "20181114",
      "classification": "Class I",
      "openfda": {},
      "recalling_firm": "Roche Diagnostics Corporation",
      "recall_number": "Z-0360-2019",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "81093",
      "termination_date": "20201016",
      "more_code_info": "",
      "recall_initiation_date": "20180913",
      "postal_code": "46256-1025",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}