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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tube, sedimentation rate
Product CodeGHC
Regulation Number 864.6700
Device Class 1

MDR Year MDR Reports MDR Events
2017 2 2
2018 15 15
2019 5 5
2020 2 2
2021 7 7
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 18 18
Incorrect Or Inadequate Test Results 11 11
Break 1 1
Leak/Splash 1 1
Device Operates Differently Than Expected 1 1
Device Displays Incorrect Message 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 17 17
No Information 6 6
No Clinical Signs, Symptoms or Conditions 6 6
No Consequences Or Impact To Patient 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Vital Diagnostics, Inc. III Jun-22-2010
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