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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ferritin, antigen, antiserum, control
Product CodeDBF
Regulation Number 866.5340
Device Class 2


Premarket Reviews
ManufacturerDecision
DIASORIN INC
  SUBSTANTIALLY EQUIVALENT 1
HORIBA ABX SAS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2021 3 3
2023 3 3
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 4 4
Non Reproducible Results 4 4
Low Test Results 2 2
Insufficient Information 1 1
Unable to Obtain Readings 1 1
Device Damaged Prior to Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7
Needle Stick/Puncture 2 2
Insufficient Information 2 2
No Consequences Or Impact To Patient 1 1
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Ireland Diagnostics Division II Aug-07-2019
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