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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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
BODITECH MED INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K170232  AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, A ...
FUJIREBIO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
SYSMEX AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 183 183
2017 235 235
2018 249 249
2019 216 260
2020 145 163
2021 109 109

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 496 511
High Test Results 367 403
Incorrect Or Inadequate Test Results 100 100
Incorrect, Inadequate or Imprecise Resultor Readings 58 58
Non Reproducible Results 55 66
Adverse Event Without Identified Device or Use Problem 28 28
High Readings 15 15
No Apparent Adverse Event 14 14
Unable to Obtain Readings 11 11
Device Damaged Prior to Use 11 11
Low Readings 10 10
Incorrect Measurement 4 4
Insufficient Information 3 3
Appropriate Term/Code Not Available 3 3
Device Operates Differently Than Expected 2 2
Nonstandard Device 1 1
False Positive Result 1 1
Device Ingredient or Reagent Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Leak/Splash 1 1
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 544 605
No Consequences Or Impact To Patient 436 436
No Clinical Signs, Symptoms or Conditions 107 107
No Code Available 22 22
No Patient Involvement 14 14
Test Result 8 9
Full thickness (Third Degree) Burn 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Radiation Exposure, Unintended 1 1
No Information 1 1
Palpitations 1 1
Underdose 1 1
Hypothermia 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 III Aug-17-2016
4 Ortho Clinical Diagnostics Inc II Oct-03-2018
5 Ortho-Clinical Diagnostics II Oct-05-2018
6 Roche Diagnostics Operations, Inc. II Oct-04-2019
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 Siemens Healthcare Diagnostics, Inc. II May-05-2017
13 Siemens Healthcare Diagnostics, Inc. II Oct-12-2016
14 Siemens Healthcare Diagnostics, Inc. II Jul-21-2016
15 Tosoh Bioscience Inc II Jun-05-2018
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