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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ldl & vldl precipitation, cholesterol via esterase-oxidase, hdl
Product CodeLBS
Regulation Number 862.1475
Device Class 1


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAROLINA LIQUID CHEMISTRIES CORP.
  SUBSTANTIALLY EQUIVALENT 1
ELITECHGROUP SEPPIM S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
LIPOSCIENCE, INC
  SUBSTANTIALLY EQUIVALENT 1
MEDICA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
  1.  K111036  EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHO ...
ORTHO-CLINICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
POLYMEDCO, INC.
  SUBSTANTIALLY EQUIVALENT 1
RANDOX LABORATORIES LTD
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS OPERATIONS (RDO)
  SUBSTANTIALLY EQUIVALENT 1

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

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 10 10
Non Reproducible Results 7 7
High Test Results 4 4
Output Problem 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8 8
No Consequences Or Impact To Patient 5 5
No Known Impact Or Consequence To Patient 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Alere San Diego, Inc. III Sep-10-2016
2 Beckman Coulter Inc. II May-12-2017
3 Ortho-Clinical Diagnostics II Nov-15-2013
4 Ortho-Clinical Diagnostics II Mar-26-2012
5 Roche Diagnostics Operations, Inc. II Jun-27-2015
6 Siemens Healthcare Diagnostics, Inc. II May-11-2016
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