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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tube, collection, capillary blood
Regulation Description Capillary blood collection tube.
Product CodeGIO
Regulation Number 864.6150
Device Class 1

MDR Year MDR Reports MDR Events
2021 2 2
2022 2 2
2023 2 2
2024 3 3
2025 3 3
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 2 2
Defective Component 1 1
Break 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9 9
Insufficient Information 2 2
Arrhythmia 1 1
Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ASP Global, LLC. dba Anatomy Supply Partners, LLC. II Nov-19-2025
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