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 reagents, specific, analyte
Product CodeMVU
Regulation Number 864.4020
Device Class 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 2 2
2016 13 13
2018 1 1
2019 1 1
2020 10 10
2021 5 5
2022 16 16
2023 3 3
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 28 28
False Positive Result 12 12
Nonstandard Device 9 9
Device Markings/Labelling Problem 5 5
Low Readings 3 3
Device Damaged Prior to Use 2 2
Device Contamination with Chemical or Other Material 2 2
Device Ingredient or Reagent Problem 1 1
False Negative Result 1 1
Fracture 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28 28
No Known Impact Or Consequence To Patient 14 14
No Consequences Or Impact To Patient 14 14
No Patient Involvement 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Molecular III Apr-23-2014
2 Abbott Molecular, Inc. III Feb-26-2024
3 BD Biosciences, Systems & Reagents II Apr-02-2015
4 BD Biosciences, Systems & Reagents II Jan-20-2015
5 BD Biosciences, Systems & Reagents II May-01-2014
6 BD Biosciences, Systems & Reagents II Dec-02-2010
7 Becton, Dickinson and Company, BD Biosciences II Jan-05-2024
8 Becton, Dickinson and Company, BD Biosciences II Jun-01-2022
9 Becton, Dickinson and Company, BD Biosciences II Aug-24-2021
10 Becton, Dickinson and Company, BD Biosciences II May-13-2020
11 Becton, Dickinson and Company, BD Biosciences II Oct-18-2016
12 Becton, Dickinson and Company, BD Biosciences III Feb-23-2016
13 Becton, Dickinson and Company, BD Biosciences III Jan-11-2016
14 Becton, Dickinson and Company, BD Biosciences II Nov-24-2015
15 Becton, Dickinson and Company, BD Biosciences II Aug-24-2015
16 Cell Marque Corporation II Jul-21-2021
17 Cell Marque Corporation II Jun-01-2017
18 Cytocell Ltd. II Jul-20-2023
19 Cytocell Ltd. II Dec-01-2022
20 Cytocell Ltd. II Nov-30-2022
21 Cytocell Ltd. III Mar-21-2022
22 Cytocell Ltd. II Aug-18-2021
23 Cytocell Ltd. II Jul-23-2021
24 Cytocell Ltd. II Apr-26-2021
25 Cytocell Ltd. II Feb-08-2021
26 Cytocell Ltd. II Aug-20-2020
27 Cytocell Ltd. III Jun-19-2019
28 Cytocell Ltd. III Apr-19-2019
29 Lab Vision Corporation II Jan-16-2014
30 Phadia US Inc III Feb-17-2012
-
-