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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
Product CodeCKA
Regulation Number 862.1030
Device Class 1

MDR Year MDR Reports MDR Events
2020 3 3
2021 2 2
2022 2 2
2023 5 5
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Unable to Obtain Readings 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
High Test Results 3 3
Low Test Results 2 2
Non Reproducible Results 2 2
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11 11
No Consequences Or Impact To Patient 3 3

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