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 tube, collection, capillary blood
Product CodeGIO
Regulation Number 864.6150
Device Class 1

MDR Year MDR Reports MDR Events
2014 4 4
2017 1 1
2019 1 1
2020 1 1
2021 2 2
2022 2 2
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 5 5
Leak/Splash 2 2
Use of Device Problem 2 2
Fitting Problem 1 1
Obstruction of Flow 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Output Problem 1 1
Material Puncture/Hole 1 1
Material Too Rigid or Stiff 1 1
Complete Blockage 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 3 3
No Clinical Signs, Symptoms or Conditions 3 3
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 2 2
Needle Stick/Puncture 1 1
Cognitive Changes 1 1
Dyspnea 1 1
Laceration(s) 1 1
Visual Impairment 1 1
No Consequences Or Impact To Patient 1 1
Toxicity 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Radiometer Medical ApS II Jun-03-2020
-
-