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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
2014 4 4
2015 8 8
2016 33 33
2017 29 29
2018 18 18
2019 26 26
2020 26 26
2021 24 24
2022 14 14
2023 24 24
2024 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 97 97
False Positive Result 70 70
False Negative Result 37 37
Incorrect Or Inadequate Test Results 29 29
Device Operates Differently Than Expected 3 3
Appropriate Term/Code Not Available 2 2
Unable to Obtain Readings 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Non Reproducible Results 1 1
Insufficient Information 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 86 86
No Clinical Signs, Symptoms or Conditions 83 83
No Consequences Or Impact To Patient 36 36
No Information 13 13
Insufficient Information 5 5
No Code Available 3 3
Patient Problem/Medical Problem 2 2
Test Result 2 2

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