TPLC - Total Product Life Cycle

• Device: cytomegalovirus (cmv) dna quantitative assay
• Definition: Cytomegalovirus (CMV) DNA Quantitative Assay is an in vitro nucleic acid assay for the quantitative measurement of CMV DNA in human plasma or whole blood. The assay can be used to measure CMV DNA levels serially at baseline and during the course of antiviral treatment to assess virological response to treatment. The test results must be interpreted within the context of all relevant clinical and laboratory findings.
• Product Code: PAB
• Device Class: 3

Premarket Approvals (PMA)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
0	0	0	3	10	4	8	7	13	24	21	8	4	9	14	4

MDR Year	MDR Reports	MDR Events
2014	1	1
2015	2	2
2016	1	1
2017	1	1
2018	2	2
2019	1	1
2022	1	1
2023	3	3
2024	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Positive Result	4	4
Incorrect Or Inadequate Test Results	2	2
High Test Results	2	2
Low Test Results	2	2
No Apparent Adverse Event	1	1
Insufficient Information	1	1
Inadequate Instructions for Healthcare Professional	1	1
Nonstandard Device	1	1
Unable to Obtain Readings	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	3	3
No Known Impact Or Consequence To Patient	2	2
Insufficient Information	2	2
No Clinical Signs, Symptoms or Conditions	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Dehydration	1	1
Unspecified Infection	1	1
Inflammation	1	1
Misdiagnosis	1	1
Electrolyte Imbalance	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Hologic, Inc.	II	Mar-22-2024