{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "197246",
      "product_res_number": "Z-0907-2023",
      "event_date_initiated": "2022-11-18",
      "event_date_posted": "2023-01-06",
      "recall_status": "Open, Classified",
      "res_event_number": "91199",
      "product_code": "PLS",
      "pma_numbers": [
        "P160002S017"
      ],
      "product_description": "VENTANA PD-L1 (SP142)\n\nVENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001\nVENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 08008540001\nVENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 07011571001",
      "code_info": "UDI-DI Code: 04015630967155\nVENTANA PD-L1 (SP142) Assay (Class III, US IVD)\n7709374001\nF30596\n\nVENTANA PD-L1 (SP142) Assay (Class III, US IVD)\n7709374001\nG27114\n\nVENTANA PD-L1 (SP142) Assay (Class III, US IVD)\n7709374001\nG31438\n\nVENTANA PD-L1 (SP142) Assay (Class III, US IVD)\n7709374001\nH03958\n\nVENTANA PD-L1 (SP142) Assay (Class III, US IVD)\n7709374001\nH13049\n\nVENTANA PD-L1 (SP142) Assay (Class III, US IVD)\n7709374001\nH35110\n\nVENTANA PD-L1 (SP142) Assay (Class III, US IVD)\n7709374001\nJ12769\n\nVENTANA PD-L1 (SP142) Assay (Class III, US IVD)\n7709374001\nJ18775\n\nVENTANA PD-L1 (SP142) Assay (Class III, US IVD)\n7709374001\nJ25361\n\nUDI-DI Code: 07613336106709\nVENTANA PD-L1 (SP142) Assay (CE IVD Predictive)\n8008540001\nF31427\n\nVENTANA PD-L1 (SP142) Assay (CE IVD Predictive)\n8008540001\nG06715\n\nVENTANA PD-L1 (SP142) Assay (CE IVD Predictive)\n8008540001\nG16831\n\nVENTANA PD-L1 (SP142) Assay (CE IVD Predictive)\n8008540001\nG24564\n\nVENTANA PD-L1 (SP142) Assay (CE IVD Predictive)\n8008540001\nH00001\n\nVENTANA PD-L1 (SP142) Assay (CE IVD Predictive)\n8008540001\nH07164\n\nVENTANA PD-L1 (SP142) Assay (CE IVD Predictive)\n8008540001\nH15132\n\nVENTANA PD-L1 (SP142) Assay (CE IVD Predictive)\n8008540001\nH18578\n\nVENTANA PD-L1 (SP142) Assay (CE IVD Predictive)\n8008540001\nH23050\n\nVENTANA PD-L1 (SP142) Assay (CE IVD Predictive)\n8008540001\nJ00572\n\nVENTANA PD-L1 (SP142) Assay (CE IVD Predictive)\n8008540001\nJ01568\n\nVENTANA PD-L1 (SP142) Assay (CE IVD Predictive)\n8008540001\nJ14244\n\nVENTANA PD-L1 (SP142) Assay (CE IVD Predictive)\n8008540001\nJ20989\n\nVENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical)\n7011571001\nH08373\n\nUDI-DI Code: 04015630976591\nVENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical)\n7011571001\nH17865\n\nVENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical)\n7011571001\nH30521\n\nVENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical)\n7011571001\nH35111\n\nVENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical)\n7011571001\nJ11932\n\nVENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical)\n7011571001\nJ20132",
      "firm_fei_number": "1000125183",
      "recalling_firm": "Ventana Medical Systems, Inc.",
      "address_1": "1910 E Innovation Park Dr",
      "city": "Oro Valley",
      "state": "AZ",
      "postal_code": "85755-1962",
      "additional_info_contact": "925-353-4412",
      "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.",
      "root_cause_description": "Process design",
      "action": "On 11/18/2022, the firm sent an \"URGENT MEDICAL DEVICE CORRECTION\", Letter via UPS ground to customer to inform them that internal comparison studies revealed unacceptable, light staining with some VENTANA PD-L1 (SP142) lots.  This can cause a reduction in both staining intensity and percent positivity, which could potentially lead to a false-negative PD-L1 result.\n\nActions required of Customers:\n1) Immediately discontinue the use of the VENTANA PD-L1 (SP142) lot numbers listed in Table 2 and discard any remaining inventory according to your local guidelines.\n2) Be aware of the new expiration dates for the VENTANA PD-L1 (SP142) lot numbers listed in Tables 3 and 4.\n3) Review negative results for the lots listed in Tables 2 and 3 as directed.\n4) Follow standard laboratory operating procedures to investigate any suspected false negative results generated with the affected lots.\n5) Consult with the physician or pathologist at their facility to determine specific clinical implications for their patients.\n6) Refer to the Product Credit section on the last page of this UMDC for the type of credit available to them and their actions needed.\n7) Complete all sections of the enclosed Recall Response Form (TP-01699) and email it to:\nroche7953@sedgwick.com even if they are not requesting product credit.\n8) Put  PD-L1 (SP142)  in the subject line of the email.\nOr fax it to 1-888-345-0279.\n9) Be aware product will not be sent nor will credit be processed until the Recall Response Form is received.\n10) Post this UMDC on or near the affected products/lots as a reminder to continuously check the expiration date and the instruction.\n11) File this Urgent Medical Device Correction (UMDC) for future reference.\n\nFor questions, contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-227-2155.",
      "product_quantity": "8,927 kits",
      "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.\n\nUpdate (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.",
      "openfda": {
        "pma_number": [
          "P150025",
          "P160002",
          "P150027",
          "P160046",
          "P150013",
          "P160006"
        ],
        "registration_number": [
          "2028492",
          "3009189893",
          "2916205",
          "2022180"
        ],
        "fei_number": [
          "3009189893",
          "1000125183",
          "2916205",
          "2022180"
        ],
        "device_name": "Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}