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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
2009
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Device
stainer, tissue, automated
Product Code
KEY
Regulation Number
864.3800
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
5
5
2015
1
1
2016
2
2
2018
2
2
2023
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
5
5
Crack
2
2
Temperature Problem
2
2
Failure To Adhere Or Bond
1
1
Break
1
1
Detachment Of Device Component
1
1
Component Falling
1
1
Overheating of Device
1
1
Increase in Pressure
1
1
Device Inoperable
1
1
Improper or Incorrect Procedure or Method
1
1
Fitting Problem
1
1
Sparking
1
1
Connection Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
7
7
No Clinical Signs, Symptoms or Conditions
1
1
No Consequences Or Impact To Patient
1
1
No Patient Involvement
1
1
Not Applicable
1
1
No Code Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Molecular
III
Aug-30-2009
2
Biogenex Laboratories
II
Mar-08-2010
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