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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
2020 34 34
2021 33 33
2022 42 42
2023 32 32
2024 22 22
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 139 139
Low Test Results 17 17
Incorrect, Inadequate or Imprecise Result or Readings 15 15
Non Reproducible Results 6 6
Mechanical Problem 1 1
Degraded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 126 126
No Known Impact Or Consequence To Patient 26 26
No Consequences Or Impact To Patient 9 9
Insufficient Information 7 7

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Feb-28-2022
2 Randox Laboratories Ltd. II Dec-08-2020
3 Siemens Healthcare Diagnostics, Inc. II Dec-26-2024
4 Siemens Healthcare Diagnostics, Inc. II Sep-26-2022
5 Siemens Healthcare Diagnostics, Inc. II Mar-28-2022
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