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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 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 824
Contamination during use 408
High Readings 357
Incorrect or inadequate test results 247
Device displays error message 241
Other (for use when an appropriate device code cannot be identified) 235
Leak 183
High test results 171
Low test results 145
Syringe, defective 116
Output issue 109
Sensor problems 92
Incorrect or inadequate result 69
Break 64
Component incompatible 49
Device operates differently than expected 48
Smoking 37
Malfunction 28
Device alarm system issue 23
No Known Device Problem 22
Missing test results 19
Unknown (for use when the device problem is not known) 19
Mechanical issue 17
Fire 12
Device handling issue 11
Low readings 10
Device Issue 10
Failure to sense 10
Failure, intermittent 10
Computer software issue 9
No code available 9
No Information 8
Device clogged 8
Imprecision 8
Electrical issue 7
Device inoperable 7
Overfill 7
Naturally worn 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
Improper device output 5
Installation-related problem 5
Electrical shorting 5
Data Issue 5
Patient Data Issue 4
Output below specifications 4
Aspiration issue 4
Device contamination with blood or blood product 4
Defective component 4
Charred 4
Shock, electrical 3
Use of Incorrect Control Settings 3
False positive result 3
Repair 3
Nonstandard device or device component 3
Spark 3
Defective item 2
Issue with displayed error message 2
Material integrity issue 2
Dislodged or dislocated 2
Loose or intermittent connection 2
Device maintenance issue 2
Perivalvular leak 2
Output above specifications 2
Sticking 2
Device stops intermittently 2
False reading from device non-compliance 2
Kinked 2
Disconnection 2
Circuit Failure 2
Detachment of device component 2
Bent 2
Blockage within device or device component 1
Delayed alarm 1
False alarm 1
Alarm, failure of warning 1
Aspiration, incomplete 1
Material disintegration 1
Corrosion 1
Crack 1
Heat 1
Error or warning message, failure to produce 1
Device expiration issue 1
Spillage, accidental 1
Shelf life exceeded 1
Air eliminator, defective 1
Electro-static discharge 1
Fitting problem 1
No device output 1
Overheating of device or device component 1
Misapplication 1
Loss of power 1
Difficult to remove 1
Replace 1
Incorrect measurement 1
Total Device Problems 3811

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