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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device analyzer, chemistry (sequential multiple, continuous flow) clinical use
Product CodeJJC
Regulation Number 862.2150
Device Class 1

MDR Year MDR Reports MDR Events
2014 6 6
2015 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Or Inadequate Test Results 5 5
Low Test Results 3 3
Device Emits Odor 2 2
High Test Results 1 1
Thermal Decomposition of Device 1 1
Image Orientation Incorrect 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 5 5
No Known Impact Or Consequence To Patient 5 5
No Patient Involvement 3 3

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