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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
Product CodeKQO
Regulation Number 862.2900
Device Class 1

MDR Year MDR Reports MDR Events
2019 64 83
2020 21 99
2021 13 13
2022 15 15
2023 19 19
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 40 41
False Positive Result 18 113
Incorrect, Inadequate or Imprecise Result or Readings 13 13
High Test Results 13 13
Non Reproducible Results 13 14
Patient Data Problem 8 8
Electrical /Electronic Property Problem 6 6
Incorrect Measurement 6 6
Fire 4 4
Smoking 2 2
No Device Output 2 2
Output Problem 2 2
Insufficient Information 2 2
Communication or Transmission Problem 2 2
Computer Operating System Problem 2 2
Electrical Shorting 1 1
Mechanical Jam 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Optical Obstruction 1 1
Delayed Program or Algorithm Execution 1 1
Unable to Obtain Readings 1 1
Use of Device Problem 1 1
Low Test Results 1 1
High Readings 1 1
Low Readings 1 1
Device Displays Incorrect Message 1 1
Leak/Splash 1 1
Misfocusing 1 1
Computer Software Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 53 53
No Clinical Signs, Symptoms or Conditions 41 41
No Known Impact Or Consequence To Patient 15 112
Urinary Tract Infection 14 14
No Patient Involvement 3 3
No Information 3 3
Insufficient Information 3 3
Test Result 1 1
Chemical Exposure 1 1
Bacterial Infection 1 1
Burn(s) 1 1
Eye Injury 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-17-2023
7 Beckman Coulter, Inc. II Mar-20-2020
8 Roche Diagnostics Operations, Inc. II Nov-18-2021
9 Sysmex America, Inc. II Apr-15-2020
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