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 triiodothyronine
Regulation Description Total triiodothyronine test system.
Product CodeCDP
Regulation Number 862.1710
Device Class 2

MDR Year MDR Reports MDR Events
2021 120 120
2022 123 123
2023 131 131
2024 41 56
2025 25 43
2026 14 33

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 348 400
Low Test Results 54 54
Non Reproducible Results 43 50
Incorrect, Inadequate or Imprecise Result or Readings 34 34
Incorrect Measurement 12 12
Low Readings 5 5
Chemical Problem 5 5
Output Problem 2 2
Insufficient Device Problem Information 2 2
Leak/Splash 2 2
False Positive Result 2 2
Appropriate Device Problem Term/Code Not Available 1 1
Optical Problem 1 1
High Readings 1 1
Manufacturing, Packaging or Shipping 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 427 479
No Consequences Or Impact To Patient 21 21
Insufficient Information 4 4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 2 2
No Known Impact Or Consequence To Patient 1 1
Hyperthyroidism 1 1
Polymyositis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter, Inc. II Apr-20-2023
2 QUIDELORTHO II May-14-2024
-
-