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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 lipoprotein, low-density, antigen, antiserum, control
Regulation Description Low-density lipoprotein immunological test system.
Product CodeDFC
Regulation Number 866.5600
Device Class 2


Premarket Reviews
ManufacturerDecision
ROCHE DIAGNOSTICS OPERATIONS
  SUBSTANTIALLY EQUIVALENT 1
SENTINEL CH. SPA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 6 6
2024 18 18
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 19 19
Non Reproducible Results 17 17
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Chemical Problem 4 4
Incorrect Measurement 2 2
Improper Chemical Reaction 2 2
Device Ingredient or Reagent Problem 1 1
Mechanical Problem 1 1
Degraded 1 1
Unable to Obtain Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 26 26

Recalls
Manufacturer Recall Class Date Posted
1 Randox Laboratories, Limited II Jan-23-2025
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