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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, specimen collection
Product CodeLIO
Regulation Number 866.2900
Device Class 1


Premarket Reviews
ManufacturerDecision
ARX SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2 2
2020 3 3
2021 11 11
2022 1 1
2023 6 6
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 7 7
Product Quality Problem 6 6
Adverse Event Without Identified Device or Use Problem 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Leak/Splash 2 2
Device Markings/Labelling Problem 1 1
Defective Device 1 1
Entrapment of Device 1 1
Contamination 1 1
Material Protrusion/Extrusion 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7
Needle Stick/Puncture 3 3
Exposure to Body Fluids 3 3
No Consequences Or Impact To Patient 3 3
Injury 2 2
Foreign Body In Patient 2 2
Insufficient Information 2 2
Headache 2 2
Abrasion 1 1
Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Thomas Scientific II Nov-13-2020
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