Recall Z-0907-2023— Ventana Medical Systems, Inc.
Class II · Ongoing
Class II FDA medical device recall by Ventana Medical Systems, Inc., initiated 2022-11-18. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Ventana Medical Systems, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-11-18
- Firm location
- Oro Valley, AZ, United States
Product 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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.