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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stainer, tissue, automated
Product CodeKEY
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
Temperature Problem 2 2
Crack 2 2
Overheating of Device 1 1
Break 1 1
Component Falling 1 1
Fitting Problem 1 1
Detachment Of Device Component 1 1
Failure To Adhere Or Bond 1 1
Improper or Incorrect Procedure or Method 1 1
Device Inoperable 1 1
Sparking 1 1
Connection Problem 1 1
Increase in Pressure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 7 7
Not Applicable 1 1
No Code Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1
No Consequences Or Impact To Patient 1 1
No Patient Involvement 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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