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TPLC
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show TPLC since
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Device
discs, strips and reagents, microorganism differentiation
Product Code
JTO
Regulation Number
866.2660
Device Class
1
MDR Year
MDR Reports
MDR Events
2015
59
59
2016
44
67
2017
42
42
2018
3
3
2019
4
4
2020
7
7
2021
10
10
2022
4
4
2023
19
19
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
123
146
Incorrect Or Inadequate Test Results
48
48
False Positive Result
6
6
Device Markings/Labelling Problem
4
4
Unable to Obtain Readings
4
4
Appropriate Term/Code Not Available
4
4
Leak/Splash
3
3
False Negative Result
1
1
Tear, Rip or Hole in Device Packaging
1
1
Low Readings
1
1
Incorrect Measurement
1
1
Contamination
1
1
Device Operates Differently Than Expected
1
1
Fluid/Blood Leak
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
90
106
No Consequences Or Impact To Patient
37
60
No Clinical Signs, Symptoms or Conditions
34
34
No Patient Involvement
34
39
No Code Available
3
3
Misdiagnosis
1
1
No Information
1
1
Skin Discoloration
1
1
Laceration(s)
1
1
Meningitis
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Becton Dickinson & Co.
II
May-29-2013
2
Becton Dickinson & Co.
III
Mar-04-2010
3
BioMerieux SA
II
Jun-12-2018
4
Biomerieux Inc
II
Jan-04-2023
5
Gibson Bioscience
II
Sep-10-2021
6
MEDLINE INDUSTRIES, LP - Northfield
II
Feb-02-2022
7
Remel Inc
II
Dec-18-2013
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