Health product recall

VENTANA PD-L1 (SP142)

Last updated

Summary

Product
VENTANA PD-L1 (SP142)
Issue
Medical devices - Performance
What to do

ROCHE DIAGNOSTICS . THE ROCHE SUPPORT NETWORK CUSTOMER SUPPORT CENTER AT 1-800-227-2155.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

VENTANA PD-L1 (SP142)

H07164
F31427
J12769
J14244
H23050
G16831
G06715
j18775
J00572
H15132
J18775
H00001
H000001

741-4860
740-4859

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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices
Companies

Ventana Medical Systems Inc

1910 E Innovation Park Drive, Tucson, Arizona, United States, 85755

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-72338

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