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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


Premarket Reviews
ManufacturerDecision
LIPOSCIENCE
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RANDOX LABORATORIES LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SEPPIM S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 6 6
2016 12 12
2017 3 3
2018 4 4
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
Device Ingredient or Reagent Problem 12 12
Low Test Results 10 10
Non Reproducible Results 10 10
High Test Results 7 7
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Incorrect Or Inadequate Test Results 3 3
Incorrect Measurement 2 2
Electrical /Electronic Property Problem 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 20 20
No Clinical Signs, Symptoms or Conditions 17 17
No Consequences Or Impact To Patient 8 8

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 Beckman Coulter Inc. II Jun-08-2016
5 Beckman Coulter Inc. II Jan-28-2015
6 Horiba Instruments Inc II Feb-02-2016
7 Ortho-Clinical Diagnostics II Oct-17-2016
8 Ortho-Clinical Diagnostics II Dec-22-2014
9 Randox Laboratories Ltd. II May-04-2018
10 Randox Laboratories Ltd. II Oct-18-2016
11 Roche Diagnostics Operations, Inc. II Jun-27-2015
12 Siemens Healthcare Diagnostics, Inc. II Aug-29-2023
13 Siemens Healthcare Diagnostics, Inc. II Nov-02-2021
14 Siemens Healthcare Diagnostics, Inc. II May-14-2016
15 Siemens Healthcare Diagnostics, Inc. II May-11-2016
16 Siemens Healthcare Diagnostics, Inc. II Mar-24-2010
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