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
Regulation Description Bicarbonate/carbon dioxide test system.
Product CodeKHS
Regulation Number 862.1160
Device Class 2

MDR Year MDR Reports MDR Events
2021 14 14
2022 10 10
2023 25 25
2024 30 30
2025 41 41
2026 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 63 63
Low Test Results 61 61
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Non Reproducible Results 1 1
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 131 131
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II May-18-2023
2 Beckman Coulter Ireland, Inc. II Dec-23-2025
3 Ortho-Clinical Diagnostics, INc. II Dec-07-2023
-
-