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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, immunity, cell mediated, mycobacterium tuberculosis
Product CodeNCD
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 3 3 1 0 4 0 3 6 5 6 6 6 8 6 4

MDR Year MDR Reports MDR Events
2015 6 6
2016 10 10
2020 1 1
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 14 14
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Nonstandard Device 2 2
Insufficient Information 1 1
Improper or Incorrect Procedure or Method 1 1
Therapeutic or Diagnostic Output Failure 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 10 10
Emotional Changes 5 5
Unspecified Infection 2 2
Complaint, Ill-Defined 1 1
Misdiagnosis 1 1
Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cellestis Inc II Feb-26-2013
2 Qiagen Sciences LLC II Mar-22-2016
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