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 enzymatic, carbon-dioxide
Product CodeKHS
Regulation Number 862.1160
Device Class 2

MDR Year MDR Reports MDR Events
2019 35 35
2020 31 31
2021 14 14
2022 10 10
2023 25 25
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 56 56
Low Test Results 49 49
Incorrect, Inadequate or Imprecise Result or Readings 25 25
Incorrect Measurement 2 2
High Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 59 59
No Known Impact Or Consequence To Patient 32 32
No Patient Involvement 20 20
No Consequences Or Impact To Patient 13 13

Recalls
Manufacturer Recall Class Date Posted
1 Abbott GmBH & Co. KG II Nov-26-2019
2 Beckman Coulter Inc. II May-18-2023
3 Ortho-Clinical Diagnostics, INc. II Dec-07-2023
-
-