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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay, thyroid-stimulating hormone
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 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

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 400 406
High Test Results 308 324
Non Reproducible Results 54 56
Incorrect, Inadequate or Imprecise Result or Readings 45 46
Adverse Event Without Identified Device or Use Problem 13 13
No Apparent Adverse Event 8 8
Insufficient Information 7 7
Incorrect Measurement 5 5
Chemical Problem 4 4
High Readings 4 4
Output Problem 2 2
Material Integrity Problem 2 2
Appropriate Term/Code Not Available 2 2
Cross Reactivity 1 1
Device Ingredient or Reagent Problem 1 1
Mechanical Problem 1 1
Low Readings 1 1
Improper Chemical Reaction 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 605 611
No Consequences Or Impact To Patient 76 76
No Known Impact Or Consequence To Patient 61 78
Insufficient Information 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Patient Involvement 4 4
Test Result 2 3
Diarrhea 1 1
Hypothermia 1 1
Polymyositis 1 1
Hormonal Imbalance 1 1
Full thickness (Third Degree) Burn 1 1

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