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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
BODITECH MED INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJIREBIO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 235 235
2018 249 249
2019 216 260
2020 145 163
2021 146 146

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 432 447
High Test Results 325 361
Incorrect Or Inadequate Test Results 71 71
Non Reproducible Results 57 68
Incorrect, Inadequate or Imprecise Resultor Readings 48 48
Adverse Event Without Identified Device or Use Problem 29 29
High Readings 15 15
No Apparent Adverse Event 14 14
Device Damaged Prior to Use 11 11
Unable to Obtain Readings 11 11
Low Readings 9 9
Incorrect Measurement 4 4
Insufficient Information 3 3
Appropriate Term/Code Not Available 2 2
Device Operates Differently Than Expected 2 2
Device Ingredient or Reagent Problem 1 1
False Positive Result 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 486 547
No Consequences Or Impact To Patient 329 329
No Clinical Signs, Symptoms or Conditions 144 144
No Patient Involvement 13 13
No Code Available 8 8
Test Result 5 6
Insufficient Information 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Palpitations 1 1
Underdose 1 1
Full thickness (Third Degree) Burn 1 1
Radiation Exposure, Unintended 1 1
No Information 1 1
Hypothermia 1 1
Polymyositis 1 1
Thyroid Problems 1 1
Misdiagnosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Ireland Diagnostics Division II Dec-22-2018
2 Clinical Diagnostic Systems III Apr-10-2018
3 Ortho Clinical Diagnostics Inc II Oct-03-2018
4 Ortho-Clinical Diagnostics II Oct-05-2018
5 Roche Diagnostics Operations, Inc. II Oct-04-2019
6 Siemens Healthcare Diagnostics, Inc. II Jul-07-2021
7 Siemens Healthcare Diagnostics, Inc. II Nov-19-2020
8 Siemens Healthcare Diagnostics, Inc. II May-09-2019
9 Siemens Healthcare Diagnostics, Inc. II Jun-01-2018
10 Siemens Healthcare Diagnostics, Inc. II May-04-2018
11 Siemens Healthcare Diagnostics, Inc. II May-05-2017
12 Tosoh Bioscience Inc II Jun-05-2018
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