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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
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
False Positive Result 59 59
Incorrect, Inadequate or Imprecise Result or Readings 55 55
False Negative Result 30 30
Unable to Obtain Readings 2 2
Non Reproducible Results 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 83 83
No Consequences Or Impact To Patient 33 33
No Known Impact Or Consequence To Patient 15 15
Insufficient Information 5 5
Patient Problem/Medical Problem 2 2

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