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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device high throughput dna sequence analyzer
Definition A high throughput sequencing technology performing targeted DNA sequencing of amplicons from a defined genetic region or a subset of genes in human genomic DNA from a clinical sample.
Product CodePFF
Regulation Number 862.2265
Device Class 2

MDR Year MDR Reports MDR Events
2021 1 1
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Component 3 3
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Chemical Exposure 2 2
Chest Pain 1 1
Sore Throat 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Illumina, Inc. II Jun-16-2023
2 Illumina, Inc. II Jun-13-2022
3 Illumina, Inc. II Mar-31-2022
4 Life Technologies Corporation II Mar-29-2024
5 Life Technologies Holdings Pte Ltd II Oct-23-2019
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