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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device acid, uric, uricase (colorimetric)
Regulation Description Uric acid test system.
Product CodeKNK
Regulation Number 862.1775
Device Class 1

MDR Year MDR Reports MDR Events
2020 2 2
2022 1 1
2023 4 4
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Non Reproducible Results 4 4
Low Test Results 3 3
High Test Results 2 2
Incorrect Measurement 1 1
Device Difficult to Setup or Prepare 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8 8
No Consequences Or Impact To Patient 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc II Mar-02-2020
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