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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device immunohistochemistry assay, antibody, programmed death-ligand 1
Definition The programmed death-ligand 1 (PD-L1) antibody is a qualitative immunohistochemical antibody intended to identify PD-L1 protein expression in human clinical tissue specimens. The PD-L1 antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs or to assess PD-L1 expression level in patients who may respond particularly well to specific FDA approved therapeutic drugs.
Product CodePLS
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 1 11 14 10 10 10 7 8 8 3

MDR Year MDR Reports MDR Events
2017 2 2
2020 1 1
2021 3 3
2022 2 2
2023 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 28 28
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 30 30
Insufficient Information 4 4
No Known Impact Or Consequence To Patient 2 2
No Code Available 1 1
Misdiagnosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Dako North America Inc. II Jul-11-2018
2 Ventana Medical Systems, Inc. II Jan-06-2023
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