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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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New Search show TPLC since Back to Search Results
Device test, time, partial thromboplastin
Product CodeGGW
Regulation Number 864.7925
Device Class 2


Premarket Reviews
ManufacturerDecision
ANIARA DIAGNOSTICA ,LLC
  SUBSTANTIALLY EQUIVALENT 1
R2 DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 2 2
2016 7 7
2017 15 15
2018 18 18
2019 3 3
2020 4 4
2021 4 4
2022 1 1
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 23 23
Adverse Event Without Identified Device or Use Problem 15 15
Low Test Results 12 12
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Use of Device Problem 2 2
Device Operates Differently Than Expected 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Off-Label Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 41 41
No Clinical Signs, Symptoms or Conditions 10 10
No Information 4 4
Intracranial Hemorrhage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Siemens Healthcare Diagnostics, Inc. II Apr-09-2013
2 Siemens Healthcare Diagnostics, Inc. II Feb-16-2012
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