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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, test, infectious mononucleosis
Product CodeKTN
Regulation Number 866.5640
Device Class 2


Premarket Reviews
ManufacturerDecision
SEKISUI DIAGNOSTICS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2 2
2020 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Suction Failure 2 2
Leak/Splash 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
Exposure to Body Fluids 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alere San Diego, Inc. III Jul-22-2016
2 Alere San Diego, Inc. III Apr-18-2013
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