{
  "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": "Oro Valley",
      "state": "AZ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "91199",
      "recalling_firm": "Ventana Medical Systems, Inc.",
      "address_1": "1910 E Innovation Park Dr",
      "address_2": "",
      "postal_code": "85755-1962",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO,CT, DC, DE, FL, GA, IL, IN, KS, KY, MA, MD, MI, MN, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, Puerto Rico, SC, TN, TX, UT, VA, VT, WA, and WI. The countries of Canada, Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom, Albania, Armenia, Bangladesh, Belarus, Costa Rica, Cote d'Ivoire, Cuba, Dominican Republic, Egypt, El Salvador, Ghana, Guatemala, Iran, Israel, Jordan, Kenya, Kosovo, Kuwait, Lebanon, Mauritius, Morocco, Myanmar, Nigeria, North Macedonia, Oman, Panama, Philippines, Russian Fed., Saudi Arabia, Serbia, South Africa, Tanzania, Turkey, Turkmenistan and United Arab Emirates.  Update (04-Jan-2023): Argentina, Australia, Brazil, Chile, China, Colombia, Ecuador, Hong Kong, Honduras, Indonesia, India, Japan, Korea, Mexico, Malaysia, New Zealand, Peru, Pakistan, Paraguay, Singapore, Thailand, Taiwan, Uruguay and Vietnam.",
      "recall_number": "Z-0907-2023",
      "product_description": "VENTANA PD-L1 (SP142)    VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001  VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 08008540001  VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 07011571001",
      "product_quantity": "8,927 kits",
      "reason_for_recall": "Internal comparison studies revealed unacceptable, light staining.  Light staining affects the borderline of positive versus negative test results. It can cause a reduction in both staining intensity and the percent positivity, which could potentially lead to a false-negative PD-L1 result.",
      "recall_initiation_date": "20221118",
      "center_classification_date": "20230106",
      "report_date": "20230118",
      "code_info": "UDI-DI Code: 04015630967155 VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 F30596  VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 G27114  VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 G31438  VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 H03958  VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 H13049  VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 H35110  VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 J12769  VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 J18775  VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 J25361  UDI-DI Code: 07613336106709 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 F31427  VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 G06715  VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 G16831  VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 G24564  VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 H00001  VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 H07164  VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 H15132  VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 H18578  VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 H23050  VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 J00572  VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 J01568  VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 J14244  VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 J20989  VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 7011571001 H08373  UDI-DI Code: 04015630976591 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 7011571001 H17865  VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 7011571001 H30521  VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 7011571001 H35111  VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 7011571001 J11932  VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 7011571001 J20132",
      "more_code_info": ""
    }
  ]
}