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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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
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 26 26
Device Markings/Labelling Problem 5 5
Low Readings 3 3
Device Contamination with Chemical or Other Material 2 2
Fracture 1 1
Device Ingredient or Reagent Problem 1 1
Device Damaged Prior to Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28 28
No Consequences Or Impact To Patient 9 9
No Patient Involvement 2 2
No Known Impact Or Consequence To Patient 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Molecular, Inc. III Feb-26-2024
2 Becton, Dickinson and Company, BD Biosciences II Jan-05-2024
3 Becton, Dickinson and Company, BD Biosciences II Jun-01-2022
4 Becton, Dickinson and Company, BD Biosciences II Aug-24-2021
5 Becton, Dickinson and Company, BD Biosciences II May-13-2020
6 Cell Marque Corporation II Jul-21-2021
7 Cytocell Ltd. II Jul-20-2023
8 Cytocell Ltd. II Dec-01-2022
9 Cytocell Ltd. II Nov-30-2022
10 Cytocell Ltd. III Mar-21-2022
11 Cytocell Ltd. II Aug-18-2021
12 Cytocell Ltd. II Jul-23-2021
13 Cytocell Ltd. II Apr-26-2021
14 Cytocell Ltd. II Feb-08-2021
15 Cytocell Ltd. II Aug-20-2020
16 Cytocell Ltd. III Jun-19-2019
17 Cytocell Ltd. III Apr-19-2019
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