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 nad reduction/nadh oxidation, lactate dehydrogenase
Regulation Description Lactate dehydrogenase test system.
Product CodeCFJ
Regulation Number 862.1440
Device Class 2

MDR Year MDR Reports MDR Events
2020 10 10
2021 10 10
2022 8 8
2023 4 4
2024 10 10
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 32 32
Non Reproducible Results 14 14
Low Test Results 4 4
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Chemical Problem 1 1
Insufficient Information 1 1
Incorrect Measurement 1 1
Installation-Related Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 32 32
No Known Impact Or Consequence To Patient 13 13

Recalls
Manufacturer Recall Class Date Posted
1 Randox Laboratories Ltd. II Sep-12-2020
-
-