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 differential rate kinetic method, cpk or isoenzymes
Regulation Description Creatine phosphokinase/creatine kinase or isoenzymes test system.
Product CodeJHS
Regulation Number 862.1215
Device Class 2

MDR Year MDR Reports MDR Events
2021 4 4
2022 3 3
2023 12 12
2024 14 14
2025 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 17 17
Low Test Results 17 17
Non Reproducible Results 10 10
Incorrect, Inadequate or Imprecise Result or Readings 9 9
Material Integrity Problem 2 2
Use of Device Problem 2 2
Incorrect Measurement 2 2
Output Problem 1 1
Appropriate Term/Code Not Available 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 43 43
Renal Failure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ortho Clinical Diagnostics Inc II Jan-05-2021
2 Roche Diagnostics Operations, Inc. II Sep-20-2024
-
-