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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
Regulation Description Ferritin immunological test system.
Product CodeJMG
Regulation Number 866.5340
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 5 5
2022 2 2
2023 13 13
2024 11 11
2025 13 13
2026 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Non Reproducible Results 31 31
Low Test Results 29 29
High Test Results 24 24
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Output Problem 4 4
Material Integrity Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
High Readings 1 1
Insufficient Device Problem 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 53 53
No Consequences Or Impact To Patient 2 2

Recalls
Manufacturer Recall Class Date Posted
1 GET TESTED INTERNATIONAL AB II Dec-01-2025
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