{
  "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": "Ongoing",
      "city": "Fremont",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "90225",
      "recalling_firm": "Microgenics Corporation",
      "address_1": "46500 Kato Rd",
      "address_2": "",
      "postal_code": "94538-7310",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S.: AL, AZ, CA, DC, FL, IA, ID, IL, KY, LA, MA, NE, NJ, NM, OH, OK, PA, SC, TN, TX, and VA  O.U.S.: Bangladesh, Brazil, Canada, Germany, India, Malaysia, Mexico, South Korea, and Thailand",
      "recall_number": "Z-1284-2022",
      "product_description": "QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET    QMS TACROLIMUS CAL A 10015566-3  QMS TACROLIMUS CAL B 10015567-3  QMS TACROLIMUS CAL C 10015568-3  QMS TACROLIMUS CAL D 10015569-3  QMS TACROLIMUS CAL E 10015570-3  QMS TACROLIMUS CAL F 10015571-3",
      "product_quantity": "615 kits",
      "reason_for_recall": "Due to QMS Tacrolimus Calibrator recovering between 82 to 94% of their target values, resulting in over-quantitation in tacrolimus patient result values when used with the QMS Tacrolimus Immunoassay.",
      "recall_initiation_date": "20220120",
      "center_classification_date": "20220624",
      "report_date": "20220706",
      "code_info": "Model/Part Number:  10015573 UDI Codes: (01) 0884883 01259 2 (17) 220310 (10) 74175462 (01) 0884883 01259 2 (17) 220512 (10) 74267412 Lot Numbers: 74175462 74267412  Calibrators within the set: QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B 10015567-3 QMS TACROLIMUS CAL C 10015568-3 QMS TACROLIMUS CAL D 10015569-3 QMS TACROLIMUS CAL E 10015570-3 QMS TACROLIMUS CAL F 10015571-3",
      "more_code_info": ""
    }
  ]
}