TPLC - Total Product Life Cycle

• Device: assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
• Product Code: MZP
• Regulation Number: 866.3170
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ROCHE MOLECULAR SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Premarket Approvals (PMA)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
11	19	20	17	24	12	12	21	15	30	35	18	8	0	0	0

MDR Year	MDR Reports	MDR Events
2014	13	13
2015	1	1
2016	12	12
2017	5	5
2018	4	4
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	18	18
Incorrect Or Inadequate Test Results	8	8
False Negative Result	6	6
Low Test Results	4	4
False Positive Result	3	3
Off-Label Use	3	3
False Reading From Device Non-Compliance	2	2
Unable to Obtain Readings	1	1
Output Problem	1	1
Data Problem	1	1
Unexpected Therapeutic Results	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	24	24
No Consequences Or Impact To Patient	8	8
No Information	3	3
No Clinical Signs, Symptoms or Conditions	2	2
Test Result	2	2
Death	2	2
Dyspnea	1	1
Exsanguination	1	1
Unspecified Infection	1	1
Therapeutic Effects, Unexpected	1	1
Complaint, Ill-Defined	1	1
Chemical Exposure	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
7	Roche Molecular Systems, Inc.	II	Jun-17-2011