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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, coagulation, automated
Regulation Description Coagulation instrument.
Product CodeGKP
Regulation Number 864.5400
Device Class 2


Premarket Reviews
ManufacturerDecision
INSTRUMENTATION LABORATORY (IL) CO.
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY COMPANY
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 17 17
2022 4 4
2023 4 4
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 7 7
Low Test Results 6 6
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Contamination /Decontamination Problem 3 3
Data Problem 2 2
Smoking 2 2
High Test Results 2 2
Improper or Incorrect Procedure or Method 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 22 22
Abrasion 5 5
Needle Stick/Puncture 2 2
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Instrumentation Laboratory II Sep-12-2023
2 Instrumentation Laboratory II Apr-28-2022
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