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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, test, her-2/neu, ihc
Product CodeMVC
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 6 6 5 13 7 7 3 5 2 7 6 1 3 2 2

MDR Year MDR Reports MDR Events
2014 1 1
2015 4 4
2016 3 3
2018 2 2
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Insufficient Information 1 1
Unclear Information 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Misdiagnosis 3 3
No Consequences Or Impact To Patient 3 3
No Known Impact Or Consequence To Patient 3 3
Therapeutic Effects, Unexpected 2 2
Breast Cancer 1 1
Breast Neoplasm 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biogenex Laboratories, Inc. II Jul-24-2014
2 Ventana Medical Systems Inc II Mar-16-2010
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