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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

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 36 36
Incorrect, Inadequate or Imprecise Result or Readings 13 13
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
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 65 65
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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