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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
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 2

MDR Year MDR Reports MDR Events
2021 146 146
2022 137 137
2023 162 163
2024 169 176
2025 104 108

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 389 392
High Test Results 316 323
Non Reproducible Results 38 40
Incorrect, Inadequate or Imprecise Result or Readings 29 30
Adverse Event Without Identified Device or Use Problem 13 13
Insufficient Information 7 8
No Apparent Adverse Event 6 6
Chemical Problem 5 5
Incorrect Measurement 5 5
Output Problem 3 3
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
Improper Chemical Reaction 1 1
False Positive Result 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 698 710
No Consequences Or Impact To Patient 10 10
Insufficient Information 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Diarrhea 1 1
Polymyositis 1 1
Hormonal Imbalance 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter, Inc. II Oct-21-2025
2 Beckman Coulter, Inc. II Jun-06-2025
3 Beckman Coulter, Inc. II Jun-05-2025
4 Beckman Coulter, Inc. II Oct-16-2024
5 GET TESTED INTERNATIONAL AB II Dec-01-2025
6 Qualigen Inc II Oct-08-2024
7 Siemens Healthcare Diagnostics, Inc. II Jun-09-2022
8 Siemens Healthcare Diagnostics, Inc. II Jul-07-2021
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