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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, thrombin time
Product CodeGJA
Regulation Number 864.7875
Device Class 2

MDR Year MDR Reports MDR Events
2015 1 1
2017 10 10
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 9 9
Incorrect Or Inadequate Test Results 2 2
Low Test Results 1 1
False Reading From Device Non-Compliance 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 10 10
No Clinical Signs, Symptoms or Conditions 2 2
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics II Mar-01-2018
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