Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device somatic gene mutation detection system
Definition The somatic gene mutation detection system is an in vitro diagnostic nucleic acid amplification and real-time detection system for the identification of genetic mutations in DNA extracted from human tumor tissues.
Product CodeOWD
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
13 12 24 9 8 9

MDR Year MDR Reports MDR Events
2021 57 57
2022 53 53
2023 15 15
2024 5 5
2025 3 3
2026 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 116 116
Non Reproducible Results 19 19
Incorrect, Inadequate or Imprecise Result or Readings 14 14
Output Problem 13 13
False Negative Result 6 6
Off-Label Use 3 3
Signal Artifact/Noise 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 129 129
Solid Tumour 98 98
No Consequences Or Impact To Patient 4 4
Diarrhea 2 2
Insufficient Information 2 2
Cancer 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Liver Damage/Dysfunction 1 1
Fatigue 1 1
Keratitis 1 1
Pneumonia 1 1
Stomatitis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Qiagen GmbH II Sep-29-2023
2 Qiagen Sciences LLC II Aug-29-2022
3 Qiagen Sciences LLC II Apr-19-2022
4 Qiagen Sciences LLC II Jan-29-2021
5 Roche Molecular Systems, Inc. II Oct-08-2021
-
-