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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 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 37 37
Incorrect, Inadequate or Imprecise Result or Readings 14 14
Incorrect Measurement 6 6
Non Reproducible Results 4 4
Computer Operating System Problem 3 3
Leak/Splash 2 2
Fire 2 2
Communication or Transmission Problem 2 2
Output Problem 2 2
No Device Output 2 2
Low Test Results 2 2
Insufficient Information 1 1
Smoking 1 1
Unable to Obtain Readings 1 1
Use of Incorrect Control/Treatment Settings 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 67 67
Urinary Tract Infection 8 8
Insufficient Information 3 3
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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