{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Brea",
      "address_1": "250 S Kraemer Blvd",
      "reason_for_recall": "Unpaired lots of AU lyophilized chemistry calibrator level 1 and 2 have been distributed. Calibrator level 1 and 2 must be paired when used for calibration and cannot be used in any other combination. If lot numbers are not correctly paired, calibration can be run using incorrect set points which may generate erroneous results. QC failures could occur if incorrect pairs of calibrators are used.",
      "address_2": "",
      "product_quantity": "unknown",
      "code_info": "Lots # 6101K51 and 6101K61",
      "center_classification_date": "20180213",
      "distribution_pattern": "Worldwide Distribution in the states of AL, AK, AZ, AK, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IO, KS, KY, LA, MA, MD, MA, MI, MN, MO, NE, NV, NH, NJ, NY, NM, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VI, WA, WV, WI, and WY  and the countries of Brazil, Canada, Costa Rica, El Salvador, Guam, Paraguay, and Peru",
      "state": "CA",
      "product_description": "Lyophilized Chemistry Calibrator Level 1     Product Usage:  Beckman Coulter Chemistry Calibrators are intended for use when calibrating methods run on the Beckman Coulter AU series of chemistry analyzers. Beckman Coulter Chemistry Calibrators are lyophilized, human serum based products formulated for use as a reference material when calibrating Beckman Coulter AU clinical chemistry system assays. The calibrators are used to calibrate the following assays: Albumin (ALB), Bicarbonate (CO2), Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Calcium Arsenazo (CALA), Calcium (CAL oCPC), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Phosphorus (PHOS), Iron, Lactate, Magnesium (MG), Total Protein (TP), Triglyceride (TRIG), Unbound Iron Binding Capacity (UIBC), Urea Nitrogen (BUN), and Uric Acid. Only lots 6101K51 and 6101K61 were subject to recall.",
      "report_date": "20180221",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Beckman Coulter Inc.",
      "recall_number": "Z-0605-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "78699",
      "termination_date": "20200828",
      "more_code_info": "",
      "recall_initiation_date": "20170824",
      "postal_code": "92821-6232",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}