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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enzymatic esterase--oxidase, cholesterol
Regulation Description Cholesterol (total) test system.
Product CodeCHH
Regulation Number 862.1175
Device Class 1


Premarket Reviews
ManufacturerDecision
ABBOTT IRELAND DIAGNOSTICS DIVISION
  SUBSTANTIALLY EQUIVALENT 1
MEDICON HELLAS S.A
  SUBSTANTIALLY EQUIVALENT 1
TRUVIAN HEALTH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 2 2
2022 4 4
2023 4 4
2024 8 8
2025 14 14
2026 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Non Reproducible Results 12 12
Incorrect, Inadequate or Imprecise Result or Readings 12 12
High Test Results 9 9
Low Test Results 8 8
Incorrect Measurement 3 3
Material Integrity Problem 2 2
Circuit Failure 1 1
Chemical Problem 1 1
Display Difficult to Read 1 1
Erratic Results 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 40 40
Insufficient Information 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Dec-20-2021
2 DFI Co., Ltd. II May-06-2026
3 Randox Laboratories Ltd. II Jul-20-2022
4 Randox Laboratories Ltd. II Dec-01-2021
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