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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device ferritin, antigen, antiserum, control
Regulation Description Ferritin immunological test system.
Product CodeDBF
Regulation Number 866.5340
Device Class 2


Premarket Reviews
ManufacturerDecision
DIASORIN INC
  SUBSTANTIALLY EQUIVALENT 1
HORIBA ABX SAS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1 1
2017 2 2
2018 7 7
2019 1 1
2020 1 1
2021 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Unable to Obtain Readings 7 7
Device Damaged Prior to Use 7 7
High Test Results 3 3
Non Reproducible Results 3 3
Low Test Results 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 6 6
No Consequences Or Impact To Patient 4 4
No Clinical Signs, Symptoms or Conditions 3 3
Needle Stick/Puncture 2 2
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Ireland Diagnostics Division II Aug-07-2019
2 Siemens Healthcare Diagnostics, Inc. II May-05-2017
3 Tosoh Bioscience Inc II Jun-05-2018
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