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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
ACON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
LABORATORY CORPORATION OF AMERICA HOLDINGS
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1 1
2019 5 5
2020 1 1
2021 2 2
2022 4 4
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Non Reproducible Results 4 4
High Test Results 3 3
Low Test Results 1 1
Circuit Failure 1 1
Display Difficult to Read 1 1
No Device Output 1 1
Erratic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 7 7
No Clinical Signs, Symptoms or Conditions 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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