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TPLC
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show TPLC since
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Device
device, microtiter diluting/dispensing
Product Code
JTC
Regulation Number
866.2500
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
2
2
2015
1
1
2019
102
102
2020
2
2
2021
8
8
2022
26
26
2023
15
15
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Nonstandard Device
96
96
Patient Data Problem
59
59
Electrical Power Problem
57
57
Use of Device Problem
56
56
Installation-Related Problem
44
44
Structural Problem
29
29
Data Problem
26
26
Incorrect, Inadequate or Imprecise Result or Readings
19
19
False Negative Result
9
9
Improper or Incorrect Procedure or Method
3
3
False Positive Result
3
3
Difficult to Open or Close
2
2
Mechanical Problem
2
2
Device Markings/Labelling Problem
1
1
Collapse
1
1
Device Fell
1
1
Maintenance Does Not Comply To Manufacturers Recommendations
1
1
Application Network Problem
1
1
Unintended System Motion
1
1
Contamination
1
1
Positioning Failure
1
1
Incorrect Or Inadequate Test Results
1
1
Device Maintenance Issue
1
1
Break
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
92
92
No Clinical Signs, Symptoms or Conditions
51
51
Test Result
7
7
Injury
2
2
Exposure to Body Fluids
2
2
No Consequences Or Impact To Patient
2
2
No Code Available
1
1
Sprain
1
1
Head Injury
1
1
Burn(s)
1
1
Burning Sensation
1
1
Swelling
1
1
Concussion
1
1
Insufficient Information
1
1
Pain
1
1
Laceration(s)
1
1
Tissue Damage
1
1
Bruise/Contusion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Becton Dickinson & Co.
II
Apr-20-2023
2
Becton Dickinson & Co.
II
Aug-30-2019
3
Copan Italia
III
Aug-30-2013
4
Hamilton Co
III
Sep-09-2009
5
Hamilton Co
II
Apr-17-2009
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