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 radioimmunoassay, total thyroxine
Product CodeCDX
Regulation Number 862.1700
Device Class 2

MDR Year MDR Reports MDR Events
2019 7 7
2020 5 5
2021 2 2
2022 7 7
2023 12 12
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 26 26
Non Reproducible Results 6 6
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Low Test Results 3 3
Incorrect Measurement 2 2
Mechanical Problem 1 1
Display or Visual Feedback Problem 1 1
False Positive Result 1 1
Chemical Problem 1 1
Improper Chemical Reaction 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 23 23
No Consequences Or Impact To Patient 8 8
No Known Impact Or Consequence To Patient 5 5

-
-