TPLC - Total Product Life Cycle

• Device: test, hiv detection
• Regulation Description: Human immunodeficiency virus (HIV) serological diagnostic and/or supplemental test.
• Product Code: MZF
• Regulation Number: 866.3956
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
	SUBSTANTIALLY EQUIVALENT	1
BECKMAN COULTER, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDMIRA LABORATORIES INC.
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	66	66
2021	65	65
2022	115	115
2023	88	88
2024	114	114
2025	44	44

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Positive Result	225	225
False Negative Result	217	217
Incorrect, Inadequate or Imprecise Result or Readings	19	19
Leak/Splash	12	12
Non Reproducible Results	8	8
Low Test Results	6	6
Use of Device Problem	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Erratic Results	3	3
High Test Results	3	3
Off-Label Use	1	1
Wrong Label	1	1
Unable to Obtain Readings	1	1
Illegible Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	404	404
No Known Impact Or Consequence To Patient	41	41
Insufficient Information	19	19
No Consequences Or Impact To Patient	11	11
No Information	9	9
Exposure to Body Fluids	6	6
No Code Available	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Chemical Exposure	2	2
Confusion/ Disorientation	2	2
Viral Infection	2	2
Anxiety	2	2
Needle Stick/Puncture	1	1
Eye Injury	1	1