Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III Recalled by Ventana Medical Systems, Inc. Due to Internal comparison studies revealed unacceptable, light staining. Light...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ventana Medical Systems, Inc. directly.
Affected Products
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
Quantity: 8,927 kits
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ventana Medical Systems, Inc.
Ventana Medical Systems, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report