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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay (two-site solid phase), ferritin
Product CodeJMG
Regulation Number 866.5340
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 2 2
2016 1 1
2017 1 1
2018 3 3
2019 1 1
2020 4 4
2021 5 5
2022 2 2
2023 13 13
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 17 17
High Test Results 13 13
Non Reproducible Results 13 13
High Readings 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Output Problem 1 1
Insufficient Information 1 1
Unable to Obtain Readings 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Device Damaged Prior to Use 1 1
Incorrect Or Inadequate Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 23 23
No Consequences Or Impact To Patient 10 10
No Known Impact Or Consequence To Patient 3 3
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Apr-17-2017
2 Siemens Healthcare Diagnostics, Inc. II Aug-08-2019
3 Siemens Healthcare Diagnostics, Inc. II Aug-15-2014
4 Siemens Healthcare Diagnostics, Inc. II Dec-24-2013
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