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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lipoprotein, low-density, antigen, antiserum, control
Product CodeDFC
Regulation Number 866.5600
Device Class 2


Premarket Reviews
ManufacturerDecision
DIAZYME LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
GENERAL ATOMICS
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SENTINEL CH. SPA
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1 1
2023 6 6
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 14 14
Non Reproducible Results 13 13
Chemical Problem 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Incorrect Measurement 2 2
Improper Chemical Reaction 2 2
Mechanical Problem 1 1
Unable to Obtain Readings 1 1
Low Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18 18
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories, Inc II Jul-19-2019
2 Wako Chemicals USA, Inc. III Apr-06-2012
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