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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
2018 1 1
2020 3 3
2021 2 2
2022 2 2
2023 3 3

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7
No Consequences Or Impact To Patient 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Aug-02-2021
2 Siemens Healthcare Diagnostics, Inc. II May-04-2018
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