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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device assay, heparin
Product CodeKFF
Regulation Number 864.7525
Device Class 2


Premarket Reviews
ManufacturerDecision
DIAGNOSTICA STAGO, INC.
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY CO.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS HEALTHCARE DIAGNOSTICS PRODCTS GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 3 3
2017 4 4
2018 5 5
2019 1 1
2021 4 4
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 11 11
Adverse Event Without Identified Device or Use Problem 5 5
Manufacturing, Packaging or Shipping Problem 1 1
Imprecision 1 1
Incorrect Or Inadequate Test Results 1 1
High Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 10 10
No Clinical Signs, Symptoms or Conditions 5 5
No Consequences Or Impact To Patient 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Diagnostica Stago, Inc. III Sep-16-2014
2 Instrumentation Laboratory II Oct-19-2021
3 International Technidyne Corp. II Jul-28-2010
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