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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
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
ORTHO-CLINICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 5 5
2020 1 1
2021 2 2
2022 4 4
2023 4 4
2024 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Non Reproducible Results 11 11
Incorrect, Inadequate or Imprecise Result or Readings 10 10
Low Test Results 7 7
High Test Results 5 5
Incorrect Measurement 3 3
Chemical Problem 2 2
Circuit Failure 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 24 24
No Consequences Or Impact To Patient 6 6
Insufficient Information 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Dec-20-2021
2 Polymer Technology Systems, Inc. III Aug-05-2019
3 Polymer Technology Systems, Inc. II May-23-2019
4 Randox Laboratories Ltd. II Jul-20-2022
5 Randox Laboratories Ltd. II Dec-01-2021
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