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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device plasma, coagulation factor deficient
Product CodeGJT
Regulation Number 864.7290
Device Class 2


Premarket Reviews
ManufacturerDecision
INSTRUMENTATION LABORATORY CO.
  SUBSTANTIALLY EQUIVALENT 2
PRECISION BIOLOGIC INC.
  SUBSTANTIALLY EQUIVALENT 1
R2 DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 1 1
2018 6 6
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 6 6
Manufacturing, Packaging or Shipping Problem 1 1
Incorrect Or Inadequate Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 8 8

Recalls
Manufacturer Recall Class Date Posted
1 Diagnostica Stago, Inc. II Mar-14-2013
2 Siemens Healthcare Diagnostics, Inc. II Jun-05-2015
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