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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)
Product CodeJIY
Regulation Number 862.1410
Device Class 1

MDR Year MDR Reports MDR Events
2020 3 3
2021 2 2
2022 3 3
2023 8 8
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 6 6
High Test Results 6 6
Low Test Results 5 5
Non Reproducible Results 4 4
No Device Output 1 1
Calibration Problem 1 1
Chemical Problem 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15 15
No Consequences Or Impact To Patient 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Sentinel CH SpA II Nov-17-2023
2 Siemens Healthcare Diagnostics, Inc. II Apr-16-2024
3 Siemens Healthcare Diagnostics, Inc. II Aug-04-2022
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