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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
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 216 260
2020 145 163
2021 146 146
2022 137 137
2023 162 162
2024 123 124

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 465 480
High Test Results 368 404
Non Reproducible Results 77 88
Incorrect, Inadequate or Imprecise Result or Readings 51 52
No Apparent Adverse Event 14 14
Adverse Event Without Identified Device or Use Problem 13 13
High Readings 10 10
Insufficient Information 6 6
Incorrect Measurement 6 6
Chemical Problem 3 3
Low Readings 3 3
Output Problem 2 2
Material Integrity Problem 2 2
Appropriate Term/Code Not Available 2 2
Cross Reactivity 1 1
Leak/Splash 1 1
Device Ingredient or Reagent Problem 1 1
Mechanical Problem 1 1
Device Damaged Prior to Use 1 1
Unable to Obtain 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 558 559
No Consequences Or Impact To Patient 184 184
No Known Impact Or Consequence To Patient 164 225
Insufficient Information 8 8
No Patient Involvement 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Code Available 3 3
Test Result 3 4
Hypothermia 1 1
Polymyositis 1 1
Underdose 1 1
Hormonal Imbalance 1 1
Full thickness (Third Degree) Burn 1 1
Thyroid Problems 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Roche Diagnostics Operations, Inc. II Oct-04-2019
2 Siemens Healthcare Diagnostics, Inc. II Jun-09-2022
3 Siemens Healthcare Diagnostics, Inc. II Jul-07-2021
4 Siemens Healthcare Diagnostics, Inc. II Nov-19-2020
5 Siemens Healthcare Diagnostics, Inc. II May-09-2019
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