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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lipase-esterase, enzymatic, photometric, lipase
Product CodeCHI
Regulation Number 862.1465
Device Class 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 5 5
2016 3 3
2017 4 4
2018 6 6
2019 2 2
2020 32 32
2021 2 2
2022 4 4
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Imprecision 30 30
High Test Results 18 18
Non Reproducible Results 6 6
Low Test Results 5 5
Nonstandard Device 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Insufficient Information 2 2
Device Ingredient or Reagent Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Incorrect Or Inadequate Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 45 45
No Clinical Signs, Symptoms or Conditions 11 11
No Consequences Or Impact To Patient 8 8

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories, Inc II Oct-28-2014
2 Horiba Instruments Incorporated II Oct-10-2019
3 Medica Corporation II May-07-2019
4 Medica Corporation II Mar-21-2018
5 Ortho-Clinical Diagnostics II Nov-15-2013
6 Ortho-Clinical Diagnostics, INc. II Nov-06-2023
7 RANDOX LABORATORIES, LTD. II Aug-04-2020
8 Siemens Healthcare Diagnostics, Inc. II Jan-30-2020
9 Siemens Healthcare Diagnostics, Inc. II Nov-14-2018
10 Siemens Healthcare Diagnostics, Inc. II May-10-2018
11 Siemens Healthcare Diagnostics, Inc. II Apr-20-2015
12 Siemens Healthcare Diagnostics, Inc. II Dec-10-2010
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