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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
Product CodeCIT
Regulation Number 862.1100
Device Class 2

MDR Year MDR Reports MDR Events
2017 2 2
2018 1 1
2019 2 2
2020 1 1
2021 5 5
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 6 6
Low Test Results 3 3
Non Reproducible Results 3 3
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Incorrect Or Inadequate Test Results 1 1
Signal Artifact/Noise 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
No Consequences Or Impact To Patient 5 5
No Known Impact Or Consequence To Patient 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Medtest Holdings, Inc. III May-18-2017
2 Siemens Healthcare Diagnostics, Inc. II May-04-2018
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