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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device reagents, specific, analyte
Product CodeMVU
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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