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TPLC
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Device
radioimmunoassay, free thyroxine
Regulation Description
Free thyroxine test system.
Product Code
CEC
Regulation Number
862.1695
Device Class
2
Premarket Reviews
Manufacturer
Decision
BECKMAN COULTER, INC
SUBSTANTIALLY EQUIVALENT
1
1. K240273
Access Free T4
ROCHE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
106
130
2021
96
96
2022
81
81
2023
99
99
2024
276
280
2025
25
27
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
517
542
Low Test Results
71
71
Incorrect, Inadequate or Imprecise Result or Readings
66
66
Non Reproducible Results
53
58
Incorrect Measurement
12
12
False Positive Result
5
5
Adverse Event Without Identified Device or Use Problem
2
2
Insufficient Information
2
2
Output Problem
2
2
Optical Problem
1
1
Unable to Obtain Readings
1
1
Human-Device Interface Problem
1
1
Appropriate Term/Code Not Available
1
1
High Readings
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
552
558
No Consequences Or Impact To Patient
108
108
Insufficient Information
11
11
No Known Impact Or Consequence To Patient
7
27
Test Result
3
7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Polymyositis
1
1
No Patient Involvement
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Beckman Coulter Inc.
II
Jun-02-2020
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