{
  "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": "2026-07-08",
    "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": "97745",
      "recalling_firm": "Microgenics Corporation",
      "address_1": "46500 Kato Rd",
      "address_2": "N/A",
      "postal_code": "94538-7310",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of AL, OK, NH, NY, WI, IL, LA, AR, TX, UT, GA, ID and the countries of MEX, CAN, KOR, MYS, DEU, GBR, BRA, JAP, HKG, NZL, AUS.",
      "recall_number": "Z-0415-2026",
      "product_description": "Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, OCRD-UL; Product Description: In Vitro Diagnostic external control",
      "product_quantity": "4462",
      "reason_for_recall": "The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may lead to as delay in patient results for hs Troponin I assays.",
      "recall_initiation_date": "20251001",
      "center_classification_date": "20251030",
      "report_date": "20251105",
      "code_info": "OCRD-UL:  UDI/DI 00884883011946, Lot Number OCRD2704U, Exp 2027-04-30;  OCRD-L:  UDI/DI 00884883011953, Lot Number OCRD2704L, Exp 2027-04-30;  OCRD-101:  UDI/DI 00884883011960, Lot Number OCRD27041, Exp 2027-04-30; OCRD-202:  UDI/DI 00884883011977, Lot Number OCRD27042, Exp 2027-04-30;  OCRD-303:  UDI/DI 00884883011984, Lot Number OCRD27043, Exp 2027-04-30;  OCRD-SP:  UDI/DI 00884883011991, Lot Number OCRD2704S, Exp 2027-04-30;  OCRD-MP:  UDI/DI 00884883012004, Lot Number OCRD2704M, Exp 2027-04-30."
    }
  ]
}