{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Raritan",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "91051",
      "recalling_firm": "Ortho-Clinical Diagnostics, Inc.",
      "address_1": "1001 Us Highway 202",
      "address_2": "N/A",
      "postal_code": "08869-1424",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution: US (Nationwide) and Countries (Foreign) including: Australia Bermuda DV04 Bermuda, HM 13 Bermuda, HM08 Brazil Canada L3R 4G5  Chile China Colombia Denmark France Germany India Italy Japan Mexico Norway Portugal Russia Singapore 609917 Spain Sweden United Kingdom",
      "recall_number": "Z-0220-2023",
      "product_description": "VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides  For in vitro diagnostic use only.  Product Code: 8568040    .  VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of ACET, CRBM, DGXN, PHBR, and PHYT",
      "product_quantity": "17,396 Units",
      "reason_for_recall": "Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathematics for VITROS Calibration Kit 9 for calibrating VITROS PHYT Slides, for  all lots of slide generation 22 (GEN 22). The erroneous mathematics on the calibration disk prevents the VITROS 250/350 Chemistry System from successfully calibrating, leading to delayed results.",
      "recall_initiation_date": "20221013",
      "center_classification_date": "20221110",
      "report_date": "20221116",
      "code_info": "UDI-DI: 10758750005031 Kit Lots/Exp. Date: 0911 24-MAY-2023; 0921 04-OCT-2023; 0942 06-JUN-2024; 0980 26-OCT-2022; 0991 01-MAR-2023   VITROS Chemistry Products PHYT Slides, GEN 22, All lots  Calibration Diskette Data Release Versions (DRVs) 6194 through 6200 supporting VITROS Calibrator Kit 9."
    }
  ]
}