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, free thyroxine
Regulation Description Free thyroxine test system.
Product CodeCEC
Regulation Number 862.1695
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 96 96
2022 81 81
2023 99 99
2024 276 280
2025 213 221
2026 16 25

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 634 655
Low Test Results 81 81
Incorrect, Inadequate or Imprecise Result or Readings 47 47
Non Reproducible Results 40 40
Incorrect Measurement 13 13
False Positive Result 6 6
Insufficient Information 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Appropriate Term/Code Not Available 2 2
Signal Artifact/Noise 1 1
Chemical Problem 1 1
Output Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
High Readings 1 1
Unable to Obtain Readings 1 1
Optical Problem 1 1
Human-Device Interface Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 752 773
No Consequences Or Impact To Patient 19 19
Insufficient Information 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Polymyositis 1 1

-
-