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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
Regulation Description Lipase test system.
Product CodeCHI
Regulation Number 862.1465
Device Class 1

MDR Year MDR Reports MDR Events
2020 32 32
2021 2 2
2022 4 4
2023 4 4
2024 7 7
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Imprecision 29 29
High Test Results 12 12
Non Reproducible Results 9 9
Low Test Results 2 2
Device Difficult to Setup or Prepare 1 1
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 29 29
No Clinical Signs, Symptoms or Conditions 20 20
No Consequences Or Impact To Patient 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Ortho-Clinical Diagnostics, INc. II Nov-06-2023
2 RANDOX LABORATORIES, LTD. II Aug-04-2020
3 Siemens Healthcare Diagnostics, Inc. II Jan-30-2020
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