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 electrode, ion based, enzymatic, creatinine
Regulation Description Creatinine test system.
Product CodeCGL
Regulation Number 862.1225
Device Class 2

MDR Year MDR Reports MDR Events
2019 25 25
2020 19 19
2021 20 20
2022 11 12
2023 5 5
2024 7 7
2025 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 42 42
Non Reproducible Results 21 21
Incorrect Measurement 13 13
Low Test Results 10 11
Insufficient Information 3 3
Erratic Results 3 3
Low Readings 3 3
Defective Component 2 2
High Test Results 2 2
Smoking 1 1
Use of Device Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 39 39
No Consequences Or Impact To Patient 16 16
Insufficient Information 9 10
No Known Impact Or Consequence To Patient 7 7
No Information 5 5
Abdominal Pain 2 2
Abnormal Blood Gases 2 2
Hematuria 2 2
Cancer 2 2
High Blood Pressure/ Hypertension 1 1
Death 1 1
Sepsis 1 1
No Code Available 1 1
Peripheral Vascular Disease 1 1
Cardiac Arrest 1 1
No Patient Involvement 1 1
Pain 1 1
Claudication 1 1
Renal Impairment 1 1
Cardiomyopathy 1 1
Sudden Cardiac Death 1 1
Premature Labor 1 1
Ischemia Stroke 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mckesson Medical-Surgical Inc. Corporate Office II May-27-2025
-
-