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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 27
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 20
UNIPATH
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Fluid leak 993
Low test results 599
Contamination during use 408
High Readings 357
Leak 271
Incorrect or inadequate test results 262
Device displays error message 247
Other (for use when an appropriate device code cannot be identified) 235
High test results 182
Output issue 146
Syringe, defective 116
Sensor problems 92
Incorrect or inadequate result 75
Break 64
Device operates differently than expected 51
Component incompatible 49
Smoking 45
No Known Device Problem 33
Malfunction 28
Missing test results 25
Device alarm system issue 23
Mechanical issue 19
Unknown (for use when the device problem is not known) 19
Fire 16
Burn of device or device component 13
Device handling issue 11
Device Issue 10
Computer software issue 10
Failure to sense 10
Low readings 10
Failure, intermittent 10
No code available 9
Device ingredient or reagent issue 9
No Information 9
Imprecision 8
Device clogged 8
Improper device output 8
Device inoperable 7
Overfill 7
Electrical issue 7
Naturally worn 7
Air leak 6
Improper or incorrect procedure or method 6
Display misread 5
Data Issue 5
Use of Device Issue 5
Installation-related problem 5
Patient Data Issue 5
Electrical shorting 5
Incorrect display 5
Charred 5
Aspiration issue 4
Output below specifications 4
Device contamination with blood or blood product 4
Defective component 4
Spark 3
False positive result 3
Output above specifications 3
Shock, electrical 3
Device maintenance issue 3
Repair 3
Use of Incorrect Control Settings 3
Nonstandard device or device component 3
Defective item 2
Split 2
Kinked 2
Loose or intermittent connection 2
Disconnection 2
Sticking 2
Detachment of device component 2
Perivalvular leak 2
Circuit Failure 2
Dislodged or dislocated 2
Bent 2
False reading from device non-compliance 2
Material integrity issue 2
Issue with displayed error message 2
Device stops intermittently 2
Device sensing issue 1
Corrosion 1
Electronic property issue 1
False alarm 1
Electro-static discharge 1
Material disintegration 1
Human-Device Interface Issue 1
Aspiration, incomplete 1
Difficult to remove 1
Incorrect measurement 1
Not Applicable 1
Difficult to open or close 1
Obstruction within device 1
Heat 1
Failure to deliver 1
Spillage, accidental 1
Replace 1
Unintended system motion 1
Air eliminator, defective 1
Normal 1
Pressure issue 1
Misapplication 1
Total Device Problems 4652

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