ClearanceBrief
Recall Z-0907-2023 ยท PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

Ventana Medical Systems, Inc.

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

DateJan 6, 2023 (initiated Nov 18, 2022)
StatusOpen, Classified
ReasonInternal 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 causeProcess design
ActionOn 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
Quantity8,927 kits
DistributionWorldwide 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, Cze
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.