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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
2020 26 26
2021 24 24
2022 14 14
2023 24 24
2024 24 24
2025 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 58 58
Incorrect, Inadequate or Imprecise Result or Readings 45 45
False Negative Result 38 38
Unable to Obtain Readings 2 2
Non Reproducible Results 1 1
Insufficient Information 1 1
Adverse Event Without Identified Device or Use Problem 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 103 103
No Consequences Or Impact To Patient 19 19
Insufficient Information 7 7
No Known Impact Or Consequence To Patient 3 3
Patient Problem/Medical Problem 2 2

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