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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
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
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 19 19
Incorrect, Inadequate or Imprecise Result or Readings 5 5
False Positive Result 2 2
Fluid/Blood Leak 1 1
Device Damaged Prior to Use 1 1
Low Test Results 1 1
Non Reproducible 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 Clinical Signs, Symptoms or Conditions 2 2
No Consequences Or Impact To Patient 2 2
Misdiagnosis 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomerieux Inc II Jan-04-2023
2 Calbiotech Inc II Mar-05-2010
3 Diamedix Corporation II Jan-07-2009
4 bioMerieux, Inc. II Dec-28-2021
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