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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
2020 31 31
2021 14 14
2022 10 10
2023 25 25
2024 31 31
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 63 63
Low Test Results 46 46
Incorrect, Inadequate or Imprecise Result or Readings 4 4
High Readings 1 1
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 85 85
No Known Impact Or Consequence To Patient 23 23
No Consequences Or Impact To Patient 7 7

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