Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Product CodeMTF
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
6 5 10 4 8 5

MDR Year MDR Reports MDR Events
2021 46 46
2022 45 45
2023 29 30
2024 31 32
2025 66 66
2026 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 125 125
Low Test Results 70 70
Incorrect Measurement 35 36
Non Reproducible Results 29 29
Incorrect, Inadequate or Imprecise Result or Readings 16 18
Output Problem 3 3
Insufficient Information 2 2
Signal Artifact/Noise 1 1
Failure to Calibrate 1 1
No Device Output 1 1
Unable to Obtain Readings 1 1
High Readings 1 1
Low Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 222 224
Osteopenia/ Osteoporosis 9 9
Insufficient Information 8 8
No Known Impact Or Consequence To Patient 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics, Inc. II Nov-14-2024
-
-