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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
Device Displays Incorrect Message 1 1
Device Operates Differently Than Expected 1 1
Break 1 1
Leak/Splash 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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