{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Irvine",
      "address_1": "34 Bunsen",
      "reason_for_recall": "HORIBA Medical is informing all ABX PENTRA Urine Control L/H customers running the Creatinine assay  on ABX PENTRA Chemistry Analyzers that the Target Range for Creatinine has been updated. The ABX PENTRA Urine Control L/H lot specific annexes have been updated to  include revised acceptable Target Ranges for Creatinine.No other analyte values  are affected.",
      "address_2": "",
      "product_quantity": "531",
      "code_info": "Model/Part #(s): A11A01674.  Lot/Serial #(s): 1207001, 1303601, and 1300701.  Shelf Life: Lot#s 1207001 & 1300701 Expire on: 06/30/2014.  Lot# 1303601 Expires on: 09/30/2014.",
      "center_classification_date": "20140203",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) and Canada.",
      "state": "CA",
      "product_description": "ABX PENTRA Urine Control L/H.    The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control  consisting of liquid solutions prepared from human urine with chemical additives and  materials of biological origin added as required to obtain given component levels. The  assigned values of the control components are given in the labeling, ensuring control of  the appropriate HORIBA ABX SAS methods on the ABX PENTRA chemistry analyzers.  Each control level is provided in one vial of 10 ml.    The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.",
      "report_date": "20140212",
      "classification": "Class III",
      "openfda": {},
      "recalling_firm": "Horiba Instruments, Inc dba Horiba Medical",
      "recall_number": "Z-0924-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "67133",
      "termination_date": "20141009",
      "more_code_info": "",
      "recall_initiation_date": "20131218",
      "postal_code": "92618-4210",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}