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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device nad reduction/nadh oxidation, lactate dehydrogenase
Product CodeCFJ
Regulation Number 862.1440
Device Class 2

MDR Year MDR Reports MDR Events
2019 18 18
2020 10 10
2021 10 10
2022 8 8
2023 4 4
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 45 45
Non Reproducible Results 7 7
Low Test Results 4 4
Chemical Problem 1 1
Installation-Related Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 30 30
No Clinical Signs, Symptoms or Conditions 23 23
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Randox Laboratories Ltd. II Sep-12-2020
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