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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
Product CodeCDT
Regulation Number 862.1705
Device Class 1

MDR Year MDR Reports MDR Events
2019 2 2
2020 2 2
2022 4 4
2023 8 8
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 7 7
Non Reproducible Results 7 7
Low Test Results 5 5
Incorrect Measurement 2 2
Incorrect, Inadequate or Imprecise Result or Readings 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 17 17
No Consequences Or Impact To Patient 2 2
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc II Mar-02-2020
2 Beckman Coulter Inc. II Oct-24-2019
3 Siemens Healthcare Diagnostics, Inc. II Aug-29-2023
4 Siemens Healthcare Diagnostics, Inc. II Nov-02-2021
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