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-esterase, enzymatic, photometric, lipase
Regulation Description Lipase test system.
Product CodeCHI
Regulation Number 862.1465
Device Class 1

MDR Year MDR Reports MDR Events
2021 2 2
2022 4 4
2023 4 4
2024 6 6
2025 11 11
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Non Reproducible Results 14 14
High Test Results 13 13
Incorrect Measurement 2 2
Low Test Results 2 2
Device Difficult to Setup or Prepare 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 29 29
Abrasion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ortho-Clinical Diagnostics, INc. II Nov-06-2023
-
-