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TPLC
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show TPLC since
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Device
reagents, specific, analyte
Product Code
MVU
Regulation Number
864.4020
Device Class
1
MDR Year
MDR Reports
MDR Events
2018
1
1
2019
1
1
2020
10
10
2021
5
5
2022
16
16
2023
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
24
24
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
Fracture
1
1
Device Ingredient or Reagent Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
26
26
No Consequences Or Impact To Patient
10
10
No Patient Involvement
2
2
No Known Impact Or Consequence To Patient
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Becton, Dickinson and Company, BD Biosciences
II
Jun-01-2022
2
Becton, Dickinson and Company, BD Biosciences
II
Aug-24-2021
3
Becton, Dickinson and Company, BD Biosciences
II
May-13-2020
4
Cell Marque Corporation
II
Jul-21-2021
5
Cytocell Ltd.
II
Jul-20-2023
6
Cytocell Ltd.
II
Dec-01-2022
7
Cytocell Ltd.
II
Nov-30-2022
8
Cytocell Ltd.
III
Mar-21-2022
9
Cytocell Ltd.
II
Aug-18-2021
10
Cytocell Ltd.
II
Jul-23-2021
11
Cytocell Ltd.
II
Apr-26-2021
12
Cytocell Ltd.
II
Feb-08-2021
13
Cytocell Ltd.
II
Aug-20-2020
14
Cytocell Ltd.
III
Jun-19-2019
15
Cytocell Ltd.
III
Apr-19-2019
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