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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device test, qualitative and quantitative factor deficiency
Regulation Description Factor deficiency test.
Product CodeGGP
Regulation Number 864.7290
Device Class 2


Premarket Reviews
ManufacturerDecision
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY CO.
  SUBSTANTIALLY EQUIVALENT 1
PRECISION BIOLOGIC
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1 1
2017 3 3
2018 3 3
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 3 3
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
Device Operates Differently Than Expected 1 1
Insufficient Information 1 1
Off-Label Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 7 7
No Information 1 1
Missing Value Reason 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Diagnostica Stago, Inc. II Apr-10-2020
2 Helena Laboratories, Inc. II Oct-12-2018
3 Instrumentation Laboratory Co. II Feb-01-2016
4 Siemens Healthcare Diagnostics, Inc. II Dec-22-2015
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