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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device photometric method, iron (non-heme)
Regulation Description Iron (non-heme) test system.
Product CodeJIY
Regulation Number 862.1410
Device Class 1

MDR Year MDR Reports MDR Events
2020 3 3
2021 2 2
2022 3 4
2023 6 7
2024 8 8
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Non Reproducible Results 13 13
High Test Results 6 8
Incorrect, Inadequate or Imprecise Result or Readings 5 6
Low Test Results 5 6
Chemical Problem 1 1
Output Problem 1 1
Insufficient Information 1 1
Material Integrity Problem 1 1
Calibration Problem 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 23 25
No Consequences Or Impact To Patient 3 3

Recalls
Manufacturer Recall Class Date Posted
1 GET TESTED INTERNATIONAL AB II Dec-01-2025
2 Sentinel CH SpA II Nov-17-2023
3 Siemens Healthcare Diagnostics, Inc. II Apr-16-2024
4 Siemens Healthcare Diagnostics, Inc. II Aug-04-2022
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