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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 57 57
High Test Results 55 55
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 120 120

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
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