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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, alt/sgpt
Regulation Description Alanine amino transferase (ALT/SGPT) test system.
Product CodeCKA
Regulation Number 862.1030
Device Class 1

MDR Year MDR Reports MDR Events
2021 2 2
2022 2 2
2023 4 5
2024 10 10
2025 9 9
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Non Reproducible Results 9 9
Incorrect, Inadequate or Imprecise Result or Readings 8 8
Low Test Results 8 9
Unable to Obtain Readings 5 5
High Test Results 3 3
Signal Artifact/Noise 1 1
False Negative Result 1 1
Incorrect Measurement 1 1
No Device Output 1 1
Output Problem 1 1
Insufficient Device Problem Information 1 1
Device Difficult to Setup or Prepare 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 30 31

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Aug-02-2021
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