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TPLC
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show TPLC since
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Device
nad reduction/nadh oxidation, lactate dehydrogenase
Product Code
CFJ
Regulation Number
862.1440
Device Class
2
Premarket Reviews
Manufacturer
Decision
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT
1
ALFA WASSERMANN, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2016
4
4
2017
15
15
2018
10
10
2019
18
18
2020
10
10
2021
10
10
2022
8
8
2023
4
4
2024
6
6
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
72
72
Non Reproducible Results
8
8
Low Test Results
4
4
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Device Ingredient or Reagent Problem
1
1
Chemical Problem
1
1
False Negative Result
1
1
Installation-Related Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
53
53
No Clinical Signs, Symptoms or Conditions
25
25
No Consequences Or Impact To Patient
4
4
No Code Available
2
2
No Patient Involvement
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Beckman Coulter Inc.
II
May-12-2017
2
Medtest Holdings, Inc.
II
May-26-2017
3
Ortho-Clinical Diagnostics
II
Nov-15-2013
4
Randox Laboratories Ltd.
II
Sep-12-2020
5
Roche Diagnostics Operations, Inc.
II
Jun-27-2015
6
Siemens Healthcare Diagnostics, Inc.
II
Nov-27-2018
7
Siemens Healthcare Diagnostics, Inc.
II
May-11-2016
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