VENTANA PD-L1 (SP142)
Brand(s)
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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