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Ventana pd-l1 (sp142)
Official notice
14 Dec 2022
Last checked
14 Dec 2022
An official Health Canada notice concerns Ventana pd-l1 (sp142). 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 Published 2022-12-14.
What to do now
Roche diagnostics . The roche support network customer support center at 1-800-227-2155.
Recall number
72338
Official notice
2022-12-14
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Ventana Medical, Ventana Pd-l1.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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