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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 assay, enzyme linked immunosorbent, hepatitis c virus
Product CodeMZO
Device Class 2


Premarket Reviews
ManufacturerDecision
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
11 13 8 0 0 0

MDR Year MDR Reports MDR Events
2019 138 138
2020 47 47
2021 26 26
2022 56 56
2023 55 55
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 252 252
Low Test Results 30 30
False Positive Result 23 23
No Apparent Adverse Event 18 18
Incorrect, Inadequate or Imprecise Result or Readings 8 8
Adverse Event Without Identified Device or Use Problem 6 6
High Test Results 3 3
Low Readings 1 1
Leak/Splash 1 1
Incorrect Measurement 1 1
Output Problem 1 1
Non Reproducible Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 154 154
No Known Impact Or Consequence To Patient 144 144
No Consequences Or Impact To Patient 37 37
Exposure to Body Fluids 2 2
Hepatitis 2 2
Misdiagnosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott GmbH II Apr-04-2024
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