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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device platelet factor 4 radioimmunoassay
Product CodeLCO
Regulation Number 864.7695
Device Class 2


Premarket Reviews
ManufacturerDecision
IMMUCOR GTI DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
INSTRUMENTATION LABORATORY CO.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 2 2
2019 4 4
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 2 2
Appropriate Term/Code Not Available 1 1
False Negative Result 1 1
False Reading From Device Non-Compliance 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
No Code Available 2 2
Insufficient Information 1 1
Test Result 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aniara Diagnostica LLC II Aug-22-2019
2 Genetic Testing Institute,inc II Jan-20-2015
3 Genetic Testing Institute,inc II Mar-28-2013
4 Hyphen BioMed II May-08-2018
5 Hyphen BioMed II Mar-15-2018
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