• 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)
2016 2017 2018 2019 2020 2021
6 12 10 8 14 2

MDR Year MDR Reports MDR Events
2016 16 16
2017 39 39
2018 30 30
2019 21 21
2020 14 14
2021 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 42 42
Low Test Results 39 39
Adverse Event Without Identified Device or Use Problem 22 22
Device Ingredient or Reagent Problem 15 15
Incorrect Or Inadequate Test Results 6 6
Incorrect, Inadequate or Imprecise Resultor Readings 4 4
No Apparent Adverse Event 4 4
Incorrect Measurement 2 2
Non Reproducible Results 2 2
Leak/Splash 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 77 77
No Consequences Or Impact To Patient 44 44
No Clinical Signs, Symptoms or Conditions 13 13
Insufficient Information 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics, Inc II Feb-04-2016
2 Siemens Healthcare Diagnostics, Inc. II Jan-31-2017
3 Siemens Healthcare Diagnostics, Inc. II Dec-22-2016
-
-