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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device molecular erythrocyte typing test
Definition Molecular determination of allelic variants that indicate erythrocyte antigen phenotypes
Product CodePEP
Device Class 3

MDR Year MDR Reports MDR Events
2021 24 24
2022 14 14
2023 24 24
2024 24 24
2025 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 53 53
False Negative Result 39 39
Incorrect, Inadequate or Imprecise Result or Readings 37 37
Unable to Obtain Readings 2 2
Non Reproducible Results 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 109 109
Insufficient Information 6 6

Recalls
Manufacturer Recall Class Date Posted
1 Luminex Corporation II May-17-2022
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