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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device nadh oxidation/nad reduction, ast/sgot
Regulation Description Aspartate amino transferase (AST/SGOT) test system.
Product CodeCIT
Regulation Number 862.1100
Device Class 2

MDR Year MDR Reports MDR Events
2020 1 1
2021 5 5
2022 2 2
2023 2 2
2024 10 10
2025 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Non Reproducible Results 12 12
High Test Results 10 10
Low Test Results 6 6
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Unable to Obtain Readings 2 2
Signal Artifact/Noise 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 26 26
No Consequences Or Impact To Patient 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Randox Laboratories Ltd. II Oct-31-2023
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