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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lipase hydrolysis/glycerol kinase enzyme, triglycerides
Regulation Description Triglyceride test system.
Product CodeCDT
Regulation Number 862.1705
Device Class 1

MDR Year MDR Reports MDR Events
2020 2 2
2022 4 4
2023 8 8
2024 10 10
2025 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Non Reproducible Results 14 14
High Test Results 11 11
Low Test Results 6 6
Incorrect Measurement 4 4
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Mechanical Problem 1 1
Output Problem 1 1
Electrical /Electronic Property Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 29 29
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc II Mar-02-2020
2 Siemens Healthcare Diagnostics, Inc. II Aug-29-2023
3 Siemens Healthcare Diagnostics, Inc. II Nov-02-2021
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