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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
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
  1.  K190773  Elecsys TSH
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 249 249
2019 216 260
2020 145 163
2021 146 146
2022 137 137
2023 101 101

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 448 463
High Test Results 347 383
Non Reproducible Results 78 89
Incorrect, Inadequate or Imprecise Result or Readings 54 54
Incorrect Or Inadequate Test Results 28 28
Adverse Event Without Identified Device or Use Problem 17 17
No Apparent Adverse Event 14 14
High Readings 13 13
Unable to Obtain Readings 12 12
Device Damaged Prior to Use 11 11
Low Readings 7 7
Insufficient Information 4 4
Incorrect Measurement 4 4
Appropriate Term/Code Not Available 2 2
Device Operates Differently Than Expected 2 2
Material Integrity Problem 1 1
Device Ingredient or Reagent Problem 1 1
Mechanical Problem 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 378 378
No Consequences Or Impact To Patient 294 294
No Known Impact Or Consequence To Patient 292 353
No Patient Involvement 13 13
Insufficient Information 6 6
Test Result 5 6
No Code Available 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Hormonal Imbalance 1 1
Full thickness (Third Degree) Burn 1 1
Palpitations 1 1
Underdose 1 1
Hypothermia 1 1
Polymyositis 1 1
Thyroid Problems 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 Jun-09-2022
7 Siemens Healthcare Diagnostics, Inc. II Jul-07-2021
8 Siemens Healthcare Diagnostics, Inc. II Nov-19-2020
9 Siemens Healthcare Diagnostics, Inc. II May-09-2019
10 Siemens Healthcare Diagnostics, Inc. II Jun-01-2018
11 Siemens Healthcare Diagnostics, Inc. II May-04-2018
12 Tosoh Bioscience Inc II Jun-05-2018
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