Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 31 31
2024 17 17
2025 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 147 147
Low Test Results 16 16
Incorrect, Inadequate or Imprecise Result or Readings 13 13
Non Reproducible Results 7 7
Mechanical Problem 1 1
Degraded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 133 133
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
-
-