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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device enzyme linked immunoabsorbent assay, rubeola igg
Regulation Description Rubeola (measles) virus serological reagents.
Definition The qualitative detection of measles specific IgG antibodies in serum or plasma.
Product CodeLJB
Regulation Number 866.3520
Device Class 1

MDR Year MDR Reports MDR Events
2015 3 3
2016 8 8
2018 1 1
2019 3 3
2020 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 18 18
Incorrect, Inadequate or Imprecise Resultor Readings 5 5
False Positive Result 2 2
Fluid Leak 1 1
Device Damaged Prior to Use 1 1
Low Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 19 19
No Patient Involvement 5 5
No Consequences Or Impact To Patient 2 2
Misdiagnosis 1 1
No Code Available 1 1

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