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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device centrifuge, hematocrit
Product CodeGKG
Regulation Number 864.6400
Device Class 2

MDR Year MDR Reports MDR Events
2019 4 4
2020 1 1
2021 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 4 4
Material Fragmentation 1 1
Leak/Splash 1 1
Improper or Incorrect Procedure or Method 1 1
Detachment of Device or Device Component 1 1
Unintended Movement 1 1
Misassembly by Users 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 4 4
No Clinical Signs, Symptoms or Conditions 2 2
Abrasion 1 1
Laceration(s) 1 1

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