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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device automated urinalysis system
Regulation Description Automated urinalysis system.
Product CodeKQO
Regulation Number 862.2900
Device Class 1


Premarket Reviews
ManufacturerDecision
ACON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
YD DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 238 238
2016 373 373
2017 20 20
2018 25 25
2019 64 64
2020 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 312 312
False Negative Result 200 200
Incorrect, Inadequate or Imprecise Resultor Readings 130 130
Leak/Splash 47 47
Pad 39 39
Probe 34 34
Fluid Leak 28 28
False Positive Result 25 25
High Test Results 24 24
Incorrect Or Inadequate Test Results 21 21
Output Problem 19 19
Low Test Results 17 17
Device Operational Issue 16 16
Patient Data Problem 13 13
Analyzer 11 11
Electrical /Electronic Property Problem 10 10
Thermal Decomposition of Device 10 10
Non Reproducible Results 9 9
Loose or Intermittent Connection 7 7
Smoking 7 7
Tube 6 6
Improper or Incorrect Procedure or Method 5 5
Computer Software Problem 4 4
Charred 3 3
Melted 3 3
Label 3 3
Circuit Board 3 3
Connector 3 3
Issue With Displayed Error Message 3 3
Product Quality Problem 3 3
Test Strip 3 3
Protective Measures Problem 3 3
Pumping Problem 3 3
Device Component Or Accessory 3 3
Fire 2 2
Device Contamination with Chemical or Other Material 2 2
Mechanical Jam 2 2
No Flow 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Use of Device Problem 2 2
Pump 2 2
Syringe 2 2
Device Emits Odor 2 2
Crack 2 2
Display Difficult to Read 1 1
Complete Blockage 1 1
Device Expiration Issue 1 1
False Reading From Device Non-Compliance 1 1
Overheating of Device 1 1
Power Conditioning Problem 1 1
Loss of Power 1 1
Failure to Power Up 1 1
Increase in Pressure 1 1
Misfocusing 1 1
Poor Quality Image 1 1
Accessory Incompatible 1 1
Altitude variations 1 1
Slide 1 1
Printer 1 1
IC (Integrated Circuit) Chip 1 1
Power Supply 1 1
Camera 1 1
Cell 1 1
Detector 1 1
Extractor 1 1
Housing 1 1
Obstruction of Flow 1 1
Failure to Calibrate 1 1
Device-Device Incompatibility 1 1
Failure of Device to Self-Test 1 1
Packaging Problem 1 1
Physical Property Issue 1 1
Improper Device Output 1 1
Inadequate Lighting 1 1
Maintenance Does Not Comply To Manufacturers Recommendations 1 1
Material Twisted/Bent 1 1
Hole In Material 1 1
Device Stops Intermittently 1 1
Device Inoperable 1 1
Defective Device 1 1
Device Displays Incorrect Message 1 1
Sparking 1 1
Calibration Problem 1 1
Communication or Transmission Problem 1 1
Computer Operating System Problem 1 1
Pipette 1 1
Insufficient Information 1 1
Data Problem 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 521 521
No Consequences Or Impact To Patient 152 152
Not Applicable 32 32
No Patient Involvement 12 12
Test Result 9 9
Urinary Tract Infection 6 6
No Information 2 2
No Code Available 1 1
Eye Injury 1 1
Complaint, Ill-Defined 1 1
Chemical Exposure 1 1
Burn(s) 1 1
Irritation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arkray Factory USA, Inc. II Jun-20-2019
2 Beckman Coulter Inc. II May-09-2020
3 Beckman Coulter Inc. II Jan-29-2020
4 Beckman Coulter Inc. II Jan-23-2020
5 Beckman Coulter Inc. II Jul-03-2019
6 Beckman Coulter Inc. II May-04-2018
7 Beckman Coulter Inc. II Apr-27-2018
8 Beckman Coulter Inc. II Apr-12-2018
9 Beckman Coulter Inc. II Apr-11-2018
10 Beckman Coulter Inc. II Mar-01-2017
11 Beckman Coulter Inc. II Mar-08-2016
12 Beckman Coulter, Inc. II Mar-20-2020
13 Iris Diagnostics II Aug-21-2015
14 Sysmex America, Inc. II Apr-15-2020
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