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TPLC
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Device
radioimmunoassay, thyroid-stimulating hormone
Product Code
JLW
Regulation Number
862.1690
Device Class
2
Premarket Reviews
Manufacturer
Decision
BECKMAN COULTER, INC.
SUBSTANTIALLY EQUIVALENT
1
ROCHE DIAGNOSTICS
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
32
32
Device Problems
MDRs with this Device Problem
Events in those MDRs
Low Test Results
404
419
High Test Results
311
347
Non Reproducible Results
73
84
Incorrect, Inadequate or Imprecise Result or Readings
50
50
No Apparent Adverse Event
14
14
Adverse Event Without Identified Device or Use Problem
13
13
High Readings
10
10
Incorrect Measurement
6
6
Insufficient Information
6
6
Low Readings
3
3
Chemical Problem
2
2
Appropriate Term/Code Not Available
2
2
Output Problem
2
2
Material Integrity Problem
2
2
Device Damaged Prior to Use
1
1
Device Ingredient or Reagent Problem
1
1
Improper Chemical Reaction
1
1
Mechanical Problem
1
1
Unable to Obtain Readings
1
1
Cross Reactivity
1
1
Leak/Splash
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
470
470
No Consequences Or Impact To Patient
184
184
No Known Impact Or Consequence To Patient
164
225
Insufficient Information
6
6
No Patient Involvement
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Test Result
3
4
No Code Available
3
3
Hormonal Imbalance
1
1
Full thickness (Third Degree) Burn
1
1
Underdose
1
1
Hypothermia
1
1
Polymyositis
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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