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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
2017 3 3
2018 4 4
2019 2 2
2020 2 2
2022 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Non Reproducible Results 7 7
Low Test Results 6 6
High Test Results 2 2
Electrical /Electronic Property Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 6 6
No Clinical Signs, Symptoms or Conditions 5 5
No Known Impact Or Consequence To Patient 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc II Mar-02-2020
2 Beckman Coulter Inc. II Oct-24-2019
3 Beckman Coulter Inc. II May-12-2017
4 Randox Laboratories Ltd. II May-04-2018
5 Siemens Healthcare Diagnostics, Inc. II Nov-02-2021
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