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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)
2016 2017 2018 2019 2020 2021 2022 2023 2024
19 16 17 11 13 8 0 0 0

MDR Year MDR Reports MDR Events
2016 115 115
2017 116 116
2018 153 153
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 421 421
Adverse Event Without Identified Device or Use Problem 102 102
Low Test Results 84 84
False Positive Result 41 41
No Apparent Adverse Event 35 35
High Test Results 23 23
Incorrect Or Inadequate Test Results 20 20
Incorrect, Inadequate or Imprecise Result or Readings 16 16
Leak/Splash 2 2
Appropriate Term/Code Not Available 2 2
Non Reproducible Results 1 1
Output Problem 1 1
Incorrect Measurement 1 1
False Reading From Device Non-Compliance 1 1
Low Readings 1 1
Chemical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 394 394
No Clinical Signs, Symptoms or Conditions 154 154
No Consequences Or Impact To Patient 107 107
No Information 31 31
No Code Available 29 29
Hepatitis 5 5
Exposure to Body Fluids 2 2
Emotional Changes 1 1
Misdiagnosis 1 1
Test Result 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott GmbH II Apr-04-2024
2 OraSure Technologies, Inc. III Apr-18-2016
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