{
  "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": [
    {
      "status": "Terminated",
      "city": "Canton",
      "state": "MI",
      "country": "United States",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "77451",
      "recalling_firm": "Medtest Holdings, Inc.",
      "address_1": "5449 Research Dr",
      "address_2": "N/A",
      "postal_code": "48188-2261",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Worldwide Distribution - US including CA, MS, NJ, PA, HI, MD, FL, OK, NV.  Foreign Distribution to CHILE",
      "recall_number": "Z-2631-2017",
      "product_description": "Pointe Scientific CRP(HS) Wide Range Control Set and  Pointe Scientific CRP(HS) Wide Range Standard Set  5 Levels of 1 x 2 ml ready to use calibrator or standard The Pointe Scientific CRP (HS) Wide Range Multi-Calibrator Set is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only. The Pointe Scientific CRP (HS) Wide Range Multi-Standard Set Is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only",
      "product_quantity": "323 vials",
      "reason_for_recall": "Individual vials of calibrator and standard were mislabeled; specifically the units on the vial labels are  incorrectly listed as mg/dl when the correct unit is mg/L.",
      "recall_initiation_date": "20090721",
      "center_classification_date": "20170626",
      "termination_date": "20170724",
      "report_date": "20170705",
      "code_info": "Model #'s  C7568-CTL and C7568-STD    Lots:  C7568-STD: 717303-131. Exp 6/2009.  C7568-CTL: 902701-111 and 902701-131. Exp 1/2011."
    }
  ]
}