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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
PRECISION BIOLOGIC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2021 11 11
2023 3 3
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 9 9
Incorrect, Inadequate or Imprecise Result or Readings 4 4
High Test Results 3 3
Insufficient Information 1 1
Moisture or Humidity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16 16
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Helena Laboratories, Corp. II Feb-11-2021
2 Helena Laboratories, Corp. II Sep-27-2019
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