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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search Show TPLC since Back To Search Results
Device enzymatic esterase--oxidase, cholesterol
Regulation Description Cholesterol (total) test system.
Product CodeCHH
Regulation Number 862.1175
Device Class 1


Premarket Reviews
ManufacturerDecision
ACON LABORATORIES INC.
  SUBSTANTIALLY EQUIVALENT 1
ACON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALERE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
POLYMER TECHNOLOGY SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
High Test Results 9
Low Test Results 8
Adverse Event Without Identified Device or Use Problem 5
Test Strip 4
Probe 3
Non Reproducible Results 2
Incorrect, Inadequate or Imprecise Result or Readings 2
Mechanical Problem 2
Device Ingredient Or Reagent 1
Valve 1
Total Device Problems 37

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II May-12-2017
2 Beckman Coulter Inc. II Jun-08-2016
3 Beckman Coulter Inc. II Jan-28-2015
4 Horiba Instruments Inc II Feb-02-2016
5 Polymer Technology Systems, Inc. III Aug-05-2019
6 Polymer Technology Systems, Inc. II May-23-2019
7 Roche Diagnostics Operations, Inc. II Jun-27-2015
8 Siemens Healthcare Diagnostics, Inc. II May-11-2016
9 Sterling Diagnostics, Inc. III Dec-29-2016

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