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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device analyzer, chemistry, centrifugal, for clinical use
Regulation Description Centrifugal chemistry analyzer for clinical use.
Product CodeJJG
Regulation Number 862.2140
Device Class 1

MDR Year MDR Reports MDR Events
2021 12 12
2022 4 4
2023 5 5
2024 4 4
2025 5 5
2026 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 15 15
Low Test Results 12 12
Low Readings 7 7
High Readings 6 6
Output Problem 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Device Emits Odor 4 4
Smoking 3 3
Operating System Version or Upgrade Problem 2 2
Temperature Problem 2 2
Accessory Incompatible 1 1
Imprecise or Erratic Results 1 1
Component Misassembled 1 1
Computer Software Problem 1 1
Excessive Heating 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 44 44
Insufficient Information 12 12

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