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TPLC
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Device
radioimmunoassay, total triiodothyronine
Regulation Description
Total triiodothyronine test system.
Product Code
CDP
Regulation Number
862.1710
Device Class
2
MDR Year
MDR Reports
MDR Events
2020
209
220
2021
120
120
2022
123
123
2023
131
131
2024
42
57
2025
4
8
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
381
410
Low Test Results
89
89
Incorrect, Inadequate or Imprecise Result or Readings
78
78
Low Readings
77
77
Non Reproducible Results
53
61
Incorrect Measurement
10
10
Output Problem
4
4
Chemical Problem
3
3
False Positive Result
2
2
Insufficient Information
2
2
Leak/Splash
2
2
High Readings
1
1
Human-Device Interface Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Optical Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
396
417
No Consequences Or Impact To Patient
108
108
No Patient Involvement
76
76
No Known Impact Or Consequence To Patient
43
51
Insufficient Information
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Test Result
2
3
Polymyositis
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Beckman Coulter Inc.
II
Jun-02-2020
2
Beckman Coulter, Inc.
II
Apr-20-2023
3
QUIDELORTHO
II
May-14-2024
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