• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Show TPLC since Back To Search Results
Device processor, tissue, automated
Regulation Description Automated tissue processor.
Product CodeIEO
Regulation Number 864.3875
Device Class 1

Device Problems
Adverse Event Without Identified Device or Use Problem 307
Improper or Incorrect Procedure or Method 186
Use of Device Problem 25
Appropriate Term/Code Not Available 20
Device Displays Incorrect Message 14
Device Operates Differently Than Expected 14
Failure to Cycle 7
Human Factors Issue 6
Mechanical Problem 5
Application Program Problem: Parameter Calculation Error 4
Programming Issue 3
Device Issue 3
Missing Value Reason 2
Fluid Leak 2
Insufficient Information 2
Device Operational Issue 2
Inadequate User Interface 2
Device Maintenance Issue 2
Degraded 1
No Apparent Adverse Event 1
Maintenance Does Not Comply To Manufacturers Recommendations 1
Device Component Or Accessory 1
Leak / Splash 1
Valve 1
Human-Device Interface Problem 1
Electrical /Electronic Property Problem 1
Installation-Related Problem 1
Mechanical Jam 1
Therapeutic or Diagnostic Output Failure 1
Tube 1
Valve, Directional 1
Component Incompatible 1
Incorrect, Inadequate or Imprecise Result or Readings 1
Unintended Movement 1
Device Handling Problem 1
Total Device Problems 623

Recalls
Manufacturer Recall Class Date Posted
1 Leica Microsystems, Inc. II Jul-03-2017
2 Leica Microsystems, Inc. II Sep-22-2015
3 Leica Microsystems, Inc. III Sep-17-2015

-
-