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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
Regulation Description Analyte specific reagents.
Product CodeMVU
Regulation Number 864.4020
Device Class 1

MDR Year MDR Reports MDR Events
2020 10 10
2021 5 5
2022 16 16
2023 3 3
2024 3 3
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 27 27
Device Markings/Labelling Problem 5 5
Low Readings 3 3
Device Contamination with Chemical or Other Material 2 2
Device Ingredient or Reagent Problem 1 1
False Negative Result 1 1
Fracture 1 1
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 30 30
No Consequences Or Impact To Patient 9 9
No Known Impact Or Consequence To Patient 2 2
No Patient Involvement 1 1
Insufficient Information 1 1

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 Kreatech Biotechnology Bv II Nov-22-2024
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