{
  "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": "Irving",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85247",
      "recalling_firm": "Abbott Laboratories",
      "address_1": "1915 Hurd Dr",
      "address_2": "N/A",
      "postal_code": "75038",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, FKL GA, IA, ID, IL, IN, KS, LA, MN, MO, NC, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TX, UT, VA, and WI; and countries of Austria, Germany, Italy, South Africa, and Spain.",
      "recall_number": "Z-1688-2020",
      "product_description": "\"HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH ARCHITECT\" - Product Usage: use in the calibration of the Hemoglobin A1c assay.",
      "product_quantity": "198 Kits",
      "reason_for_recall": "Calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot. The manufacturer observed no impact to assay performance between the HbA1c concentration range of 5.33% to 6.87%. However, outside of this range, a bias of greater than 3% may be seen with patient results. The device failure that is associated with this recall can result in potentially negatively and positively biased patient test results for HbA1c. The firm is investigating the root cause.",
      "recall_initiation_date": "20190522",
      "center_classification_date": "20200409",
      "termination_date": "20210122",
      "report_date": "20200415",
      "code_info": "List Number: 4P52-01  Lot Number: 54582UQ02"
    }
  ]
}