• 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, thyroid-stimulating hormone
Regulation Description Thyroid stimulating hormone test system.
Product CodeJLW
Regulation Number 862.1690
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
GENALYTE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 145 163
2021 146 146
2022 137 137
2023 162 162
2024 171 177
2025 59 61

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 428 434
High Test Results 339 356
Non Reproducible Results 55 58
Incorrect, Inadequate or Imprecise Result or Readings 46 47
Adverse Event Without Identified Device or Use Problem 13 13
No Apparent Adverse Event 8 8
Insufficient Information 7 7
Incorrect Measurement 7 7
Chemical Problem 5 5
High Readings 4 4
Material Integrity Problem 2 2
Output Problem 2 2
Appropriate Term/Code Not Available 2 2
Cross Reactivity 1 1
False Positive Result 1 1
Mechanical Problem 1 1
No Device Output 1 1
Low Readings 1 1
Device Ingredient or Reagent Problem 1 1
Improper Chemical Reaction 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 664 672
No Consequences Or Impact To Patient 76 76
No Known Impact Or Consequence To Patient 61 78
Insufficient Information 8 8
No Patient Involvement 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Test Result 2 3
Diarrhea 1 1
Hypothermia 1 1
Full thickness (Third Degree) Burn 1 1
Hormonal Imbalance 1 1
Polymyositis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter, Inc. II Jun-06-2025
2 Beckman Coulter, Inc. II Jun-05-2025
3 Beckman Coulter, Inc. II Oct-16-2024
4 Qualigen Inc II Oct-08-2024
5 Siemens Healthcare Diagnostics, Inc. II Jun-09-2022
6 Siemens Healthcare Diagnostics, Inc. II Jul-07-2021
7 Siemens Healthcare Diagnostics, Inc. II Nov-19-2020
-
-