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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device photometric method, magnesium
Regulation Description Magnesium test system.
Product CodeJGJ
Regulation Number 862.1495
Device Class 1

MDR Year MDR Reports MDR Events
2021 33 33
2022 42 43
2023 31 33
2024 17 17
2025 22 22
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 118 119
Incorrect, Inadequate or Imprecise Result or Readings 14 16
Low Test Results 14 14
Non Reproducible Results 7 9
Degraded 1 1
Mechanical Problem 1 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 138 141
Insufficient Information 7 7
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Feb-28-2022
2 Siemens Healthcare Diagnostics, Inc. II Dec-26-2024
3 Siemens Healthcare Diagnostics, Inc. II Sep-26-2022
4 Siemens Healthcare Diagnostics, Inc. II Mar-28-2022
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