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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, fibrinogen determination
Product CodeKQJ
Regulation Number 864.7340
Device Class 2

MDR Year MDR Reports MDR Events
2015 1 1
2019 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Or Inadequate Test Results 1 1
High Test Results 1 1
Manufacturing, Packaging or Shipping Problem 1 1

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

Recalls
Manufacturer Recall Class Date Posted
1 Fisher Diagnostics II Jul-25-2017
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