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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
2022 4 4
2023 7 7
2024 5 5
2025 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Non Reproducible Results 13 13
High Test Results 10 10
Incorrect Measurement 4 4
Low Test Results 4 4
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Mechanical Problem 1 1
Output Problem 1 1
Material Integrity Problem 1 1
Device Difficult to Setup or Prepare 1 1
Calibration Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28 28

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