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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)
2018 2019 2020 2021 2022 2023
17 11 13 8 0 0

MDR Year MDR Reports MDR Events
2018 153 153
2019 138 138
2020 47 47
2021 26 26
2022 56 56
2023 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 244 244
Adverse Event Without Identified Device or Use Problem 76 76
Low Test Results 47 47
No Apparent Adverse Event 33 33
False Positive Result 26 26
Incorrect, Inadequate or Imprecise Result or Readings 8 8
Incorrect Or Inadequate Test Results 6 6
High Test Results 4 4
Low Readings 1 1
Chemical Problem 1 1
Leak/Splash 1 1
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 257 257
No Clinical Signs, Symptoms or Conditions 93 93
No Consequences Or Impact To Patient 59 59
No Code Available 14 14
Hepatitis 3 3
Exposure to Body Fluids 2 2
Misdiagnosis 1 1
No Information 1 1

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