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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, automated platelet aggregation
Product CodeJOZ
Regulation Number 864.5700
Device Class 2


Premarket Reviews
ManufacturerDecision
AGGREDYNE, INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJIMORI KOGYO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 9 9
2020 2 2
2021 2 2
2022 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 19 19
Incorrect, Inadequate or Imprecise Result or Readings 6 6
High Test Results 3 3
Insufficient Information 1 1
Non Reproducible Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18 18
No Known Impact Or Consequence To Patient 10 10
Death 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Accriva Diagnostics, Inc. II May-20-2022
2 Aggredyne, Inc. II Aug-26-2022
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