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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Product CodeMZP
Regulation Number 866.3170
Device Class 2


Premarket Reviews
ManufacturerDecision
ROCHE MOLECULAR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
35 18 8 0 0 0

MDR Year MDR Reports MDR Events
2019 5 5
2020 1 1
2021 1 1
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Output Problem 1 1
Unable to Obtain Readings 1 1
Low Test Results 1 1
Off-Label Use 1 1
Data Problem 1 1
False Positive Result 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Test Result 1 1
Death 1 1
Chemical Exposure 1 1
Exsanguination 1 1
Dyspnea 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Molecular, Inc. II Nov-29-2023
2 Abbott Molecular, Inc. II Aug-12-2022
3 Abbott Molecular, Inc. II Jan-06-2022
4 Abbott Molecular, Inc. II Jan-06-2022
5 Abbott Molecular, Inc. II Jan-06-2022
6 Abbott Molecular, Inc. II Jan-06-2022
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