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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 system, test, low density, lipoprotein
Product CodeMRR
Regulation Number 862.1475
Device Class 1


Premarket Reviews
ManufacturerDecision
NUMARES AG
  SUBSTANTIALLY EQUIVALENT 1
RANDOX LABORATORIES LIMITED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 3 3
2018 2 2
2020 1 1
2021 1 1
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 5 5
Non Reproducible Results 2 2
Temperature Problem 1 1
Burst Container or Vessel 1 1
Melted 1 1
Loss of Power 1 1
Unable to Obtain Readings 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 3 3
No Known Impact Or Consequence To Patient 3 3
No Clinical Signs, Symptoms or Conditions 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Ortho-Clinical Diagnostics II Nov-17-2018
2 Siemens Healthcare Diagnostics, Inc. II Aug-29-2023
3 Siemens Healthcare Diagnostics, Inc. II May-11-2016
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