• 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 Back To Search Results
Device counter, differential cell
Regulation Description Automated differential cell counter.
Product CodeGKZ
Regulation Number 864.5220
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 27
BAYER
  SUBSTANTIALLY EQUIVALENT 5
BD
  SUBSTANTIALLY EQUIVALENT 12
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 26
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
KULZER
  SUBSTANTIALLY EQUIVALENT 3
NOVA
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
SYSMEX
  SUBSTANTIALLY EQUIVALENT 19
UNIPATH
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Fluid leak 729
Contamination during use 408
High Readings 357
Incorrect or inadequate test results 243
Device displays error message 240
Other (for use when an appropriate device code cannot be identified) 235
High test results 170
Low test results 144
Leak 140
Syringe, defective 116
Sensor problems 92
Output issue 88
Incorrect or inadequate result 64
Break 64
Component incompatible 49
Device operates differently than expected 46
Smoking 36
Malfunction 28
Device alarm system issue 23
Unknown (for use when the device problem is not known) 19
No Known Device Problem 18
Mechanical issue 17
Missing test results 13
Fire 12
Low readings 10
Failure to sense 10
Failure, intermittent 10
No code available 9
Device handling issue 9
Device Issue 8
Imprecision 8
Computer software issue 8
Device clogged 8
Electrical issue 7
Device inoperable 7
Overfill 7
Naturally worn 7
No Information 7
Device ingredient or reagent issue 6
Improper or incorrect procedure or method 6
Burn of device or device component 6
Air leak 5
Display misread 5
Incorrect display 5
Use of Device Issue 5
Electrical shorting 5
Improper device output 5
Installation-related problem 5
Output below specifications 4
Device contamination with blood or blood product 4
Aspiration issue 4
Data Issue 4
Patient Data Issue 3
Spark 3
Repair 3
Nonstandard device or device component 3
Shock, electrical 3
Use of Incorrect Control Settings 3
False positive result 3
Charred 3
Circuit Failure 2
Detachment of device component 2
Bent 2
False reading from device non-compliance 2
Kinked 2
Disconnection 2
Loose or intermittent connection 2
Device maintenance issue 2
Perivalvular leak 2
Output above specifications 2
Defective component 2
Sticking 2
Device stops intermittently 2
Defective item 2
Material integrity issue 2
Issue with displayed error message 2
Dislodged or dislocated 2
Device sensing issue 1
Difficult to open or close 1
Electronic property issue 1
Expulsion 1
Foreign material present in device 1
Manufacturing or shipping issue associated with device 1
Incorrect device or component shipped 1
Split 1
Malposition of device 1
Blocked connection 1
Failure to deliver 1
Dissatisfaction 1
Cut in material 1
Positioning Issue 1
Pressure issue 1
Protective measure issue 1
Temperature issue 1
Not Applicable 1
Spillage, accidental 1
Shelf life exceeded 1
Air eliminator, defective 1
Electro-static discharge 1
Fitting problem 1
Total Device Problems 3616

-
-