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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 877
Low test results 429
Contamination during use 408
High Readings 357
Incorrect or inadequate test results 249
Device displays error message 245
Other (for use when an appropriate device code cannot be identified) 235
Leak 210
High test results 173
Output issue 123
Syringe, defective 116
Sensor problems 92
Incorrect or inadequate result 72
Break 64
Component incompatible 49
Device operates differently than expected 48
Smoking 39
Malfunction 28
No Known Device Problem 23
Missing test results 23
Device alarm system issue 23
Unknown (for use when the device problem is not known) 19
Mechanical issue 17
Fire 14
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
Burn of device or device component 7
Device inoperable 7
Naturally worn 7
Overfill 7
Device ingredient or reagent issue 6
Improper device output 6
Improper or incorrect procedure or method 6
Use of Device Issue 5
Air leak 5
Display misread 5
Incorrect display 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
Charred 4
Defective component 4
Repair 3
Nonstandard device or device component 3
Shock, electrical 3
Use of Incorrect Control Settings 3
False positive result 3
Spark 3
Dislodged or dislocated 2
Issue with displayed error message 2
Defective item 2
Material integrity issue 2
False reading from device non-compliance 2
Kinked 2
Disconnection 2
Circuit Failure 2
Detachment of device component 2
Bent 2
Loose or intermittent connection 2
Device maintenance issue 2
Perivalvular leak 2
Output above specifications 2
Sticking 2
Device stops intermittently 2
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
Normal 1
Device emits odor 1
Unintended collision 1
Unintended system motion 1
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
Total Device Problems 4211

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