VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IVD Pr

FDA device recall Z-0907-2023 · posted 2023-01-06 · Open, Classified

Recall details

Recalling firm

Ventana Medical Systems, Inc.

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.

Action taken

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: roche7953@sedgwick.com 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.

Root cause

Process design

Status

Open, Classified

Product code

PLS

Quantity affected

8,927 kits

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,

Date initiated

2022-11-18

Date posted

2023-01-06

Location

Oro Valley, AZ