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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

MDR Year MDR Reports MDR Events
2021 13 13
2022 15 15
2023 19 19
2024 20 20
2025 12 12
2026 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 40 40
Incorrect, Inadequate or Imprecise Result or Readings 14 14
Non Reproducible Results 6 6
Incorrect Measurement 6 6
Output Problem 4 4
Computer Operating System Problem 4 4
Leak/Splash 2 2
Fire 2 2
Communication or Transmission Problem 2 2
No Device Output 2 2
Low Test Results 2 2
Smoking 1 1
Unable to Obtain Readings 1 1
Insufficient Device Problem Information 1 1
Mechanics Altered 1 1
Use of Incorrect Control/Treatment Settings 1 1
Date/Time-Related Software Problem 1 1
Data Problem 1 1
Electrical Shorting 1 1
Computer Software Problem 1 1
Delayed Program or Algorithm Execution 1 1
Optical Obstruction 1 1
Intermittent Program or Algorithm Execution 1 1
Device Displays Incorrect Message 1 1
Mechanical Jam 1 1
Misfocusing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 74 74
Urinary Tract Infection 10 10
Insufficient Information 4 4
Fall 1 1
Eye Injury 1 1
Bacterial Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter, Inc. II May-17-2023
2 Roche Diagnostics Operations, Inc. II Nov-18-2021
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