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TPLC
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show TPLC since
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Device
radioimmunoassay, total triiodothyronine
Product Code
CDP
Regulation Number
862.1710
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
343
378
2020
209
220
2021
120
120
2022
123
123
2023
131
131
2024
22
22
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
464
504
Low Readings
212
212
Low Test Results
170
174
Incorrect, Inadequate or Imprecise Result or Readings
79
79
Non Reproducible Results
68
70
Incorrect Measurement
10
10
Output Problem
3
3
Insufficient Information
2
2
High Readings
2
2
False Positive Result
2
2
Leak/Splash
2
2
Chemical Problem
2
2
Human-Device Interface Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Optical Problem
1
1
Failure to Calibrate
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
374
376
No Consequences Or Impact To Patient
227
227
No Patient Involvement
212
212
No Known Impact Or Consequence To Patient
131
174
Test Result
2
3
Insufficient Information
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Polymyositis
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Ireland Diagnostics Division
II
Feb-04-2019
2
Beckman Coulter Inc.
II
Jun-02-2020
3
Beckman Coulter, Inc.
II
Apr-20-2023
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