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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
Product CodeMTG
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
3 9 25 17 12 13 7 3 9 7 9 13 7 4 9 0

MDR Year MDR Reports MDR Events
2014 1 1
2015 9 9
2016 5 5
2017 8 8
2018 12 12
2019 13 13
2020 6 6
2021 9 9
2022 4 4
2023 5 5
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 39 39
Incorrect Measurement 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Incorrect Or Inadequate Test Results 7 7
Low Test Results 7 7
Non Reproducible Results 5 5
Incorrect, Inadequate or Imprecise Result or Readings 4 4
No Apparent Adverse Event 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 32 32
No Known Impact Or Consequence To Patient 24 24
No Clinical Signs, Symptoms or Conditions 18 18

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc II Sep-16-2009
2 Beckman Coulter Inc. III May-22-2012
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