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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device activated partial thromboplastin
Product CodeGFO
Regulation Number 864.7925
Device Class 2


Premarket Reviews
ManufacturerDecision
INSTRUMENTATION LABORATORY CO.
  SUBSTANTIALLY EQUIVALENT 1
PRECISION BIOLOGIC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 2 2
2015 2 2
2016 3 3
2017 19 19
2018 4 4
2019 1 1
2021 11 11
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 16 16
Adverse Event Without Identified Device or Use Problem 15 15
Low Test Results 9 9
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Nonstandard Device 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 27 27
No Clinical Signs, Symptoms or Conditions 14 14
No Information 3 3
Abdominal Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Diagnostica Stago, Inc. II Dec-14-2018
2 Helena Laboratories, Corp. II Feb-11-2021
3 Helena Laboratories, Corp. II Sep-27-2019
4 ITC-Nexus Dx II Feb-06-2014
5 Siemens Healthcare Diagnostics, Inc. II Jun-02-2015
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