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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
ABAXIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT IRELAND DIAGNOSTICS DIVISION
  SUBSTANTIALLY EQUIVALENT 1
ACON LABORATORIES INC.
  SUBSTANTIALLY EQUIVALENT 1
ACON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
ALFA WASSERMANN, INC.
  SUBSTANTIALLY EQUIVALENT 1
AXIS-SHIELD POC AS
  SUBSTANTIALLY EQUIVALENT 1
HITACHI CHEMICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
LABORATORY CORPORATION OF AMERICA HOLDINGS
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
POLYMER TECHNOLOGY SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RANDOX LABORATORIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
VITAL DIAGNOSTICS PTY. LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2016 5 5
2017 2 2
2018 1 1
2019 5 5
2020 1 1
2021 2 2
2022 4 4
2023 4 4
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 8 8
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Non Reproducible Results 7 7
Low Test Results 4 4
Chemical Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Circuit Failure 1 1
Display Difficult to Read 1 1
Incorrect Measurement 1 1
No Device Output 1 1
Erratic Results 1 1
Incorrect Or Inadequate Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15 15
No Consequences Or Impact To Patient 13 13
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Alere San Diego II Feb-06-2012
2 Beckman Coulter Inc. II Dec-20-2021
3 Beckman Coulter Inc. II May-12-2017
4 Beckman Coulter Inc. II Jun-08-2016
5 Beckman Coulter Inc. II Jan-28-2015
6 Diagnostic Chemicals, Ltd. III Dec-16-2010
7 Horiba Instruments Inc II Feb-02-2016
8 Ortho-Clinical Diagnostics II Nov-15-2013
9 Polymer Technology Systems, Inc. III Aug-05-2019
10 Polymer Technology Systems, Inc. II May-23-2019
11 Polymer Technology Systems, Inc. III Apr-02-2010
12 Polymer Technology Systems, Inc. II Mar-15-2010
13 Polymer Technology Systems, Inc. II Mar-01-2010
14 Randox Laboratories Ltd. II Jul-20-2022
15 Randox Laboratories Ltd. II Dec-01-2021
16 Roche Diagnostics Operations, Inc. II Jun-27-2015
17 Siemens Healthcare Diagnostics, Inc. II May-11-2016
18 Sterling Diagnostics, Inc. III Dec-29-2016
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