VENTANA PD-L1 (SP142)
Brand(s)
Summary
ROCHE DIAGNOSTICS . THE ROCHE SUPPORT NETWORK CUSTOMER SUPPORT CENTER AT 1-800-227-2155.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
VENTANA PD-L1 (SP142) |
H07164 |
741-4860 |
Issue
During internal comparison studies, unacceptable light staining with some VENTANA PD-L1 (SP142) on-markets lots were confirmed which 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.
Recall start date: November 28, 2022
Additional information
Details
Ventana Medical Systems Inc
1910 E Innovation Park Drive, Tucson, Arizona, United States, 85755
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