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 lipase hydrolysis/glycerol kinase enzyme, triglycerides
Regulation Description Triglyceride test system.
Product CodeCDT
Regulation Number 862.1705
Device Class 1

MDR Year MDR Reports MDR Events
2022 4 4
2023 7 7
2024 5 5
2025 12 12
2026 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Non Reproducible Results 17 17
High Test Results 11 11
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Incorrect Measurement 6 6
Low Test Results 6 6
Output Problem 2 2
Chemical Problem 1 1
Mechanical Problem 1 1
Material Integrity Problem 1 1
Device Difficult to Setup or Prepare 1 1
Calibration Problem 1 1
Ambient Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 43 43

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics, Inc. II Aug-29-2023
2 Siemens Healthcare Diagnostics, Inc. II Nov-02-2021
-
-