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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
Product CodeJGJ
Regulation Number 862.1495
Device Class 1

MDR Year MDR Reports MDR Events
2019 31 31
2020 34 34
2021 33 33
2022 42 42
2023 32 32
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 149 149
Low Test Results 17 17
Incorrect, Inadequate or Imprecise Result or Readings 17 17
Non Reproducible Results 3 3
Degraded 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 107 107
No Known Impact Or Consequence To Patient 51 51
No Consequences Or Impact To Patient 13 13
Insufficient Information 7 7
No Patient Involvement 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories, Inc II Mar-01-2019
2 Beckman Coulter Inc. II Feb-28-2022
3 Randox Laboratories Ltd. II Dec-08-2020
4 Siemens Healthcare Diagnostics, Inc. II Sep-26-2022
5 Siemens Healthcare Diagnostics, Inc. II Mar-28-2022
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