Reported Jan 18, 2023 · Ongoing
VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IVD…
Ventana Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ventana Medical Systems, Inc. · 1910 E Innovation Park Dr · Oro Valley, AZ · 85755-1962
Is this the product you have?
- 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
- Lot codes and dates
- UDI-DI Code04015630967155 VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 F30596 VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 G27114 VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 G31438 VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 H03958 VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 H13049 VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 H35110 VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 J12769 VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 J18775 VENTANA PD-L1 (SP142) Assay (Class III
- US IVD) 7709374001 J25361 UDI-DI Code07613336106709 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 F31427 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 G06715 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 G16831 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 G24564 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 H00001 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 H07164 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 H15132 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 H18578 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 H23050 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 J00572 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 J01568 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 J14244 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 J20989 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 7011571001
- H08373 UDI-DI Code04015630976591 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 7011571001 H17865 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 7011571001 H30521 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 7011571001 H35111 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 7011571001 J11932 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 7011571001 J20132
- Amount recalled
- 8,927 kits
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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