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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
2019 2 2
2020 32 32
2021 2 2
2022 4 4
2023 4 4
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Imprecision 30 30
High Test Results 11 11
Non Reproducible Results 9 9
Low Test Results 3 3
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 31 31
No Clinical Signs, Symptoms or Conditions 17 17
No Consequences Or Impact To Patient 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Horiba Instruments Incorporated II Oct-10-2019
2 Medica Corporation II May-07-2019
3 Ortho-Clinical Diagnostics, INc. II Nov-06-2023
4 RANDOX LABORATORIES, LTD. II Aug-04-2020
5 Siemens Healthcare Diagnostics, Inc. II Jan-30-2020
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