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TPLC
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show TPLC since
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Device
lambda, antigen, antiserum, control
Product Code
DEH
Regulation Number
866.5550
Device Class
2
Premarket Reviews
Manufacturer
Decision
SENTINEL CH. SPA
SUBSTANTIALLY EQUIVALENT
1
THE BINDING SITE GROUP, LTD.
SUBSTANTIALLY EQUIVALENT
1
VENTANA MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
3
3
2019
8
8
2020
3
3
2021
12
12
2022
7
7
2023
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Low Test Results
22
22
High Test Results
11
11
Incorrect, Inadequate or Imprecise Result or Readings
3
3
Improper or Incorrect Procedure or Method
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
24
24
No Known Impact Or Consequence To Patient
11
11
Renal Failure
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
The Binding Site Group, Ltd.
II
Nov-19-2021
2
The Binding Site Group, Ltd.
II
Jan-19-2017
3
The Binding Site Group, Ltd.
II
Jan-19-2017
4
The Binding Site Group, Ltd.
II
Jan-18-2017
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