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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
Regulation Description Hepatitis C virus antibody tests.
Product CodeMZO
Regulation Number 866.3169
Device Class 2


Premarket Reviews
ManufacturerDecision
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
8 0 0 0 0 0

MDR Year MDR Reports MDR Events
2021 26 26
2022 56 56
2023 55 55
2024 56 56
2025 210 210
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 252 252
False Positive Result 129 129
Incorrect, Inadequate or Imprecise Result or Readings 18 18
Non Reproducible Results 15 15
Low Test Results 4 4
Incorrect Measurement 3 3
Leak/Splash 2 2
High Test Results 2 2
No Apparent Adverse Event 2 2
Improper or Incorrect Procedure or Method 2 2
Material Integrity Problem 1 1
Output Problem 1 1
Device Difficult to Maintain 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 393 393
Insufficient Information 5 5
No Consequences Or Impact To Patient 3 3
Hepatitis 2 2
Exposure to Body Fluids 2 2
Viral Infection 1 1

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