BEUDAMED
    FDA Recall Open, Classified

    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

    Recall: Z-0907-2023 · Initiated November 18, 2022

    Recall

    Recall Number
    Z-0907-2023
    Event Number
    91199
    Firm
    Ventana Medical Systems, Inc.
    FEI Number
    1000125183
    Product Code
    PLS
    Status
    Open, Classified
    Root Cause
    Process design
    Initiated
    November 18, 2022
    Posted
    January 6, 2023
    Address
    1910 E Innovation Park Dr, Oro Valley, AZ, 85755-1962

    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

    Reason

    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.

    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. Actions required of Customers: 1) 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. 2) Be aware of the new expiration dates for the VENTANA PD-L1 (SP142) lot numbers listed in Tables 3 and 4. 3) Review negative results for the lots listed in Tables 2 and 3 as directed. 4) Follow standard laboratory operating procedures to investigate any suspected false negative results generated with the affected lots. 5) Consult with the physician or pathologist at their facility to determine specific clinical implications for their patients. 6) 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. 7) Complete all sections of the enclosed Recall Response Form (TP-01699) and email it to: [email protected] even if they are not requesting product credit. 8) Put PD-L1 (SP142) in the subject line of the email. Or fax it to 1-888-345-0279. 9) Be aware product will not be sent nor will credit be processed until the Recall Response Form is received. 10) Post this UMDC on or near the affected products/lots as a reminder to continuously check the expiration date and the instruction. 11) File this Urgent Medical Device Correction (UMDC) for future reference. For questions, contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-227-2155.

    Distribution

    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.

    Quantity

    8,927 kits