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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
ACCUMETRICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AGGREDYNE, INC.
  SUBSTANTIALLY EQUIVALENT 3
CHRONO-LOG CORP.
  SUBSTANTIALLY EQUIVALENT 1
CORAMED TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
FUJIMORI KOGYO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VERUM DIAGNOSTICA GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2017 1 1
2018 25 25
2019 9 9
2020 2 2
2021 2 2
2022 16 16
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 26 26
Low Test Results 20 20
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Leak/Splash 1 1
Non Reproducible Results 1 1
Insufficient Information 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Device Inoperable 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 35 35
No Clinical Signs, Symptoms or Conditions 19 19
Death 1 1
No Code Available 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Accriva Diagnostics, Inc. II May-20-2022
2 Accumetrics Inc II Mar-11-2014
3 Accumetrics Inc II Dec-11-2013
4 Accumetrics Inc II Jun-21-2012
5 Aggredyne, Inc. II Aug-26-2022
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