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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device diazonium colorimetry, urobilinogen (urinary, non-quant.)
Product CodeCDM
Regulation Number 862.1785
Device Class 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 4 4
2017 1 1
2018 1 1
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 4 4
Device Operates Differently Than Expected 4 4
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Incorrect Or Inadequate Test Results 1 1
False Positive Result 1 1
Material Integrity Problem 1 1
Material Discolored 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 7 7
Insufficient Information 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Clarity Diagnostics Llc III Jul-24-2018
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